zli12321/Bills huggingface dataset:
FDA Renewing Efficiency From Outside Reviewer Management Act of 2011 - Amends the Federal Food, Drug, and Cosmetic Act to revise and extend through October 1, 2017, provisions authorizing accredited persons to provide classification reports for a medical device and to inspect class II device or class III device facilities. Deems a recommendation of an accredited person as to the classification of a medical device to be accepted by the Secretary of Health and Human Services (HHS) if the Secretary fails to make a determination with respect to the recommendation within 30 days. Requires the Secretary to regularly publish: (1) detailed decision summaries for each clearance of a device, classification of a device, approval of an application of a device, or grant of exemption for a device occurring after the enactment of this Act; and (2) total product life cycles information for devices. Expands the devices for which an accredited person may perform a review to include: (1) a class II device for which clinical data is required in the report, and (2) a class II device which is intended to be permanently implantable or life sustaining or supporting only if notification is provided to the Secretary before such a review. Deems the review permissible if the Secretary does not object within 60 days. Requires the Secretary to provide for the initial training and periodic updating of training of accredited persons. Makes accreditation valid for three years. Sets forth provisions regarding reaccreditation. Prohibits an accredited person from being a sole practitioner. Provides that the prohibitions against an accredited person being owned or controlled by a manufacturer, supplier, or vendor of devices or engaging in the design, manufacture, promotion, or sale of devices shall apply only if the devices are of the same type for which the person is accredited.

Date: 2011-10-14
Topic: Health (Drug Industry)
Subject: Health
Cultivating Scientific Expertise to Foster Innovation for Patients Act of 2011 - Amends the Federal Food, Drug, and Cosmetic Act to revise provisions related to financial interests of Food and Drug Administration (FDA) advisory committee members to require the Secretary of Health and Human Services (HHS) to ensure that individual appointments to advisory committees are made to promote scientific and technical expertise while at the same time minimizing any potential conflicts of interest. Requires the Secretary to consider, with respect to any financial interest constituting a potential conflict of interest, the type, nature, and magnitude of the financial interest. Declares that no specific factor shall be dispositive in the Secretary's evaluation of a particular financial interest. Repeals the prohibition specifically applicable to FDA that prevents a member of an advisory committee from participating with respect to a particular matter if such individual or an immediate family member of such individual has a financial interest that could be affected by the advice given to the Secretary.

Date: 2011-10-14
Topic: Health (Drug Industry)
Subject: Health
Modernizing Laboratory Test Standards for Patients Act of 2011 - Amends the Public Health Service Act to require the Secretary of Health and Human Services (HHS) to establish a single publicly accessible test registry data bank of laboratory-developed tests and direct-to-consumer DNA tests, which shall include information on the purpose of each test, the claimed use or uses of each test, and information regarding the analytical validity of each test. Requires notification to the Secretary: (1) before marketing such a test, (2) after any significant modification of such a test, or (3) if the evidence of clinical validity is inadequate to support one or more of the claimed uses. Requires the Secretary, within 90 days of receiving such notification, to determine whether the notification demonstrates clinical validity. Deems the Secretary to have authorized marketing of the test if no response is received within 90 days. Gives the Secretary authority to order a laboratory or test-offering entity to cease offering or marketing a test if the information submitted in notifications does not demonstrate the clinical validity of the claimed uses and the test poses a risk of immediate harm to the public health. Sets forth requirements for: (1) registration of a test-offering entity, (2) information that must be included in disseminated materials and advertising, (3) notice to the Secretary if a test may have caused or contributed to a death or serious bodily injury, and (4) sanctions for violations of this Act. Requires the Secretary to administer this section solely through the Centers for Medicare and Medicaid Services (CMS).

Date: 2011-10-14
Topic: Health (Drug Industry)
Subject: Health
Patients Come First Act of 2011 - Directs the Secretary of Health and Human Services (HHS): (1) within 90 days after enactment of this Act, to establish the schedule required under the Federal Food, Drug, and Cosmetic Act for the promulgation of regulations requiring premarket approval for medical devices required to remain in class III; and (2) not later than one year after the schedule is established, to issue a final regulation for each such device. Directs the Secretary to: (1) establish a program to assess information relating to device recalls and use such information to proactively identify strategies for mitigating health risks presented by defective or unsafe devices, (2) clarify procedures for conducting device recall audit checks to improve the ability of investigators to perform those checks in a consistent manner, (3) develop detailed criteria for assessing whether a person performing a device recall has performed an effective correction or action plan for the recall, and (4) document the basis for each Food and Drug Administration (FDA) termination of a device recall.

Date: 2011-10-14
Topic: Health (Drug Industry)
Subject: Health
Premarket Predictability Act of 2011 - Amends the Federal Food, Drug, and Cosmetic Act to require the Secretary of Health and Human Services (HHS) to assign a tracking number to a medical device upon submission of: (1) an application for an exemption of a device for investigational use, (2) a request to classify a device, or (3) a premarket report or notification related to a device. Requires the Secretary to use the tracking number to record interactions between the Secretary and applicant with respect to the device. Directs the Secretary to: (1) assign a reviewer with prior review experience with the type of of device or technology involved or other relevant expertise to review an application for an exemption of a device for investigational use, and (2) evaluate whether the investigational study can be conducted ethically with reasonable risk in determining whether to grant an exemption for investigational use. Prohibits the Secretary from disapproving an application because the investigation does not or may not meet any requirement relating to the approval or clearance of a device because the Secretary believes that a different clinical testing design or plan could produce data more relevant to an approval or clearance decision. Revises the procedures relating to submission of an application to investigate a class II or a class III device, which may include a plan for determining whether the device is substantially equivalent to or is at least as safe and effective as a legally marketed device that is not subject to premarket approval requirements. Sets forth requirements for the Secretary to meet in determining the least burdensome appropriate means of evaluating medical device effectiveness that would have a reasonable likelihood of resulting in approval. Requires the Secretary to document the scientific and regulatory rationale for any significant decision of the Center for Devices and Radiological Health regarding device review, approval, or exemption. Sets forth appeal procedures. Requires the Secretary to regularly publish detailed decision summaries for each clearance of a device not requiring premarket approval.

Date: 2011-10-14
Topic: Health (Drug Industry)
Subject: Health
Humanitarian Device Reform Act of 2011 - Amends the Federal Food, Drug, and Cosmetic Act to repeal provisions that prohibit the sale of a medical device approved under the humanitarian device exemption (available for devices designed to treat or diagnose a disease or condition that affects fewer than 4,000 individuals in the United States) for an amount that exceeds the costs of research and development, fabrication, and distribution of the device. Adds provisions clarifying that the 4,000 individuals that must be affected in the United States under the humanitarian device exemption is 4,000 individuals per year so affected.

Date: 2011-10-14
Topic: Health (Drug Industry)
Subject: Health
Keeping America Competitive Through Harmonization Act of 2011 - Amends the Federal Food, Drug, and Cosmetic Act to require the Secretary of Health and Human Services (HHS) to enter into agreements with listed countries (countries eligible for exports of drugs or biological products that have not been approved under certain circumstances) regarding methods and approaches to harmonizing regulatory requirements for premarket review, inspections, and common international labeling symbols. Requires the Secretary to report on the agreements entered under this Act and to itemize the methods and approaches that have been harmonized pursuant to this Act.

Date: 2011-10-14
Topic: Health (Drug Industry)
Subject: Health
Affordable Medicines Utilization Act of 2011 - Amends title XIX (Medicaid) of the Social Security Act (SSA), with respect to FY2012-FY2014, to require an increase in the quarterly Medicaid payment to a state by 50% of the generic drug utilization savings amount if the state's generic substitution rate for the most recent preceding fiscal year for which data is available is greater than its rate for the most recent second preceding fiscal year for which data is available. Directs the Secretary of Health and Human Services (HHS) to determine the state's generic substitution rate for such fiscal years. Defines "generic substitution rate" as the share of all drug units for which Medicaid payment is made to a state for the 20 most widely prescribed multiple source drugs under the state program that have a specific National Drug Code. Directs the Secretary to provide for payments to eligible states for implementation of programs to achieve reductions in expenditures under Medicaid or under SSA title XVIII (Medicare) (innovative health care savings program).

Date: 2011-11-03
Topic: Health (Drug Industry)
Subject: Health
Dietary Supplement Protection Act of 2011 - Amends the Federal Food, Drug, and Cosmetic Act to exempt dietary supplements containing a dietary ingredient marketed before January 1, 2007 (currently, October 15, 1994) from the requirement to provide premarket evidence of safety for the dietary ingredient to the Secretary of Health and Human Services (HHS).

Date: 2011-11-04
Topic: Health (Drug Industry)
Subject: Health
Everson Walls and Ron Springs Gift for Life Act of 2011 - Amends the Public Health Service Act to direct the Secretary of Health and Human Services (HHS), acting through the Administrator of the Health Resources and Services Administration, to establish a National Organ and Tissue Donor Registry Resource Center, which shall: (1) advance the development, expansion, and evaluation of state organ and tissue donor registries; (2) facilitate timely access to, and the exchange of accurate donor information between, such registries; (3) ensure that registries funded through this Act comply with applicable requirements; (4) provide technical assistance to states for such registries; and (5) maintain a registry information clearinghouse to collect, synthesize, and disseminate best practices information. Requires the Secretary to award grants or cooperative agreements to states for the development, enhancement, expansion, and evaluation of organ and tissue donor registries. Sets forth requirements for registries, including that such registries: (1) allow a donor to include a statement or symbol that the donor has made, amended, or revoked an anatomical gift; (2) allow organ procurement organizations to access that information, at or near the donor's death; and (3) bar the use or disclosure of personally identifiable information for any other purpose without the donor's consent. Prohibits any person from being held civilly liable for having harvested or taken an individual's organs or tissues without obtaining valid consent if: (1) such person verified that the individual was registered as a donor with a state organ and tissue donor registry, and (2) the harvesting or taking was within the scope of the consent given for purposes of such registration. Directs the Comptroller General to report on the feasibility of establishing a living donor database to track health effects for donors associated with living organ donation.

Date: 2011-11-29
Topic: Health (Drug Industry)
Subject: Health
Unlocking Lifesaving Treatments for Rare-Diseases Act or ULTRA - Amends the Federal Food, Drug, and Cosmetic Act to authorize the Secretary of Health and Human Services (HHS) to approve an application for a drug as a fast track product using a surrogate endpoint, based on the existence of reasonable scientific data that support and qualify the relevance of such endpoint to the disease state and treatment, if the Secretary: (1) makes an initial determination that the drug is eligible for approval as a drug designated for a rare disease or condition (orphan drug) and as a fast track product, and (2) determines that the drug is a treatment for a disease or condition that affects a small number of patients in the United States. Prohibits the Secretary from requiring clinical treatment or other historical clinical data on such endpoint as a prerequisite to assessment of that endpoint if such scientific data is not available. Directs the Secretary to issue guidance providing details and options for qualifying surrogate endpoints without clinical data, taking into account and balancing: (1) the unmet need served by the drug and the adverse effects of the rare disease or condition on quality and length of life, (2) the very low likelihood that clinical data would exist or that clinical studies would be completed to support a surrogate endpoint due to the small size of the U.S. patient population and other significant barriers inherent in performing such studies due to the prevalence of the disease or related factors, and (3) the full scope of available basic scientific data and information that the Secretary deems reasonably predictive of a clinical benefit in the absence of clinical data.

Date: 2011-12-20
Topic: Health (Drug Industry)
Subject: Health
Drug Shortage Prevention Act of 2012 - Amends the Federal Food, Drug, and Cosmetic Act to direct the Secretary of Health and Human Services (HHS) to: (1) define the term "critical drug" based on the medical necessity and vulnerability to shortage of a drug or biological product; (2) establish, make publicly available, and update semiannually a list identifying each critical drug and its manufacturers; (3) promptly remove from such list any drug or biological product that no longer meets such definition; and (4) establish, make publicly available, and update monthly a list identifying each critical drug that is in a critical drug shortage in the United States, the severity of and reason for the shortage, alternate therapies and regions particularly affected, and an estimated date by which the necessary quantities of the drug will begin reaching providers. Allows manufacturers to request removal of a drug from such lists on the basis that it doesn't meet the definition of "critical drug" or is not in a critical drug shortage. Directs the Secretary to: (1) establish a proactive system for giving notice to the public concerning modifications to the critical drug shortage list, (2) establish a system for giving notice of any imminent critical drug shortage to critical drug manufacturers and wholesale distributors and manufacturers of alternative therapies, (3) notify the Attorney General of any critical drug shortage, (4) study the feasibility of creating a national contingency plan addressing critical drug shortages, (5) expedite the review of applications for approval of critical drugs and requests by sponsors of such drugs to approve manufacturing process changes or alternate suppliers of active ingredients, and (6) improve the process for regulating critical drugs. Express the sense of Congress that the Food and Drug Administration (FDA) should increase the number of personnel responsible for identifying and addressing critical drug shortages. Amends the Controlled Substances Act to direct the Attorney General to increase a quota as appropriate for a drug listed in a critical drug shortage that is or contains a controlled substance.

Date: 2012-01-31
Topic: Health (Drug Industry)
Subject: Health
Safety Of Untested and New Devices Act of 2012 or the SOUND Devices Act of 2012 - Amends the Federal Food, Drug, and Cosmetic Act to require a medical device company seeking approval of a new device based on a determination of substantial equivalence to a predicate device to inform the Food and Drug Administration (FDA) if any predicate lineage products have harmed device recipients and to explain how the current device avoids past flaws. Prohibits finding a new device substantially equivalent to a predicate device if the predicate has been removed from the market by the Secretary of Health and Human Services (HHS) or determined to be misbranded or adulterated by judicial order. Permits the FDA to reject a claim of substantial equivalency for a device whose predicate has been corrected or removed from the market by its sponsor. Requires the Secretary to maintain an up-to-date database for purposes of determining whether devices are eligible for use as a predicate device. Requires each manufacturer's corrective action or removal of device report to contain the root cause of each defect leading to the corrective action or removal. Requires a manufacturer's report for devices in the same lineage as devices that have been subject to corrections or removals and requires such report to explain why the subsequent device does not share the flaws of its predecessor device. Requires the Secretary to conduct a review of all covered devices to identify any such devices with respect to which a predicate device, or any device in the full device lineage, has been corrected or removed from the market pursuant to a Class I or Class II recall.

Date: 2012-01-31
Topic: Health (Drug Industry)
Subject: Health
Amends the Pediatric Medical Device Safety and Improvement Act to authorize appropriations through FY2017 for grants for demonstration projects to promote pediatric device development. Amends the Federal Food, Drug, and Cosmetic Act to allow an exception to the prohibition against selling a device that is designed to treat or diagnose a disease or condition which affects fewer than 4,000 individuals in the United States and that is exempt from the effectiveness requirements of such Act for an amount that exceeds the costs of research and development, fabrication, and distribution of the device where the request for such exemption is submitted on or before October 1, 2017 (currently, October 1, 2012). Requires the proposed rule issued by the Commissioner of Food and Drugs (FDA) entitled "Medical Devices; Pediatric Uses of Devices; Requirement for Submission of Information on Pediatric Subpopulations That Suffer From a Disease or Condition That a Device Is Intended to Treat, Diagnose, or Cure" to take effect on January 1, 2013, unless such Commissioner issues the final rule before such date.

Date: 2012-02-08
Topic: Health (Drug Industry)
Subject: Health
Religious Liberty Protection Act of 2012 - Prohibits the Secretary of Health and Human Services (HHS) from implementing or enforcing any provision of the interim final rule published on July 19, 2010, related to the coverage of preventive health services under the Patient Protection and Affordable Care Act (PPACA) or any amendment to such rule insofar as such provision or amendment require any individual or entity to provide coverage of sterilization or contraceptive services to which the individual or entity is opposed on the basis of religious belief. Amends PPACA to declare that a health plan shall not be considered to have failed to provide essential health benefits, to fail to be a qualified health plan, or to fail to fulfill any other requirements on the basis that the plan does not provide or pay for coverage of sterilization or contraceptive services because: (1) providing or paying for such coverage is contrary to the religious or moral beliefs of the sponsor, issuer, or other entity offering the plan; or (2) such coverage, in the case of individual coverage, is contrary to the religious or moral beliefs of the purchaser or beneficiary of the coverage.

Date: 2012-02-08
Topic: Health (Drug Industry)
Subject: Health
Generic Drug and Biosimilar User Fee Act of 2012 - Amends the Federal Food, Drug, and Cosmetic Act to direct the Secretary of Health and Human Services (HHS), beginning FY2013, to assess and collect the following fees related to generic drugs: (1) a one-time backlog fee for abbreviated new drug applications pending on October 1, 2012; (2) a drug master file fee; (3) an abbreviated new drug application and prior approval supplement filing fee, as well as an additional fee for active pharmaceutical ingredient information not included by reference to Type II active pharmaceutical ingredient drug master file; and (4) a generic drug facility fee and active pharmaceutical ingredient facility fee. Provides that submission of an application for a positron emission tomography drug or active pharmaceutical ingredient for a positron emission tomography drug shall not require the payment of any fee. Sets forth provisions relating to fee amounts and due dates. Terminates the above provisions on October 1, 2017. Requires the Secretary to report to Congress on the progress of the Food and Drug Administration (FDA) in achieving specified safety, access, and transparency goals with respect to generic drugs. Biosimilar User Fee Act of 2012 - Directs the Secretary, beginning FY2013, to assess and collect the following fees related to biosimilar biological products: (1) biosimilar program development fees, encompassing an initial biosimilar biological development fee, an annual biosimilar biological product development fee, and a reactivation fee; (2) a biosimilar biological product application and supplement fee; (3) a biosimilar biological product establishment fee; and (4) a biosimilar biological product fee. Waives the above fees for the first biosimilar biological product application of a small business. Terminates the above provisions on October 1, 2017. Requires the Secretary to report to Congress on the progress of the Food and Drug Administration (FDA) in achieving specified goals with respect to biosimilar biological products.

Date: 2012-02-08
Topic: Health (Drug Industry)
Subject: Health
Protecting Consumer Access to Generic Drugs Act of 2012 - Prohibits, as an unfair and deceptive act or practice and an unfair method of competition in or affecting interstate commerce, any person from being a party to any agreement resolving or settling a patent infringement claim in which: (1) an abbreviated new drug (generic) application filer receives anything of value; and (2) such filer agrees not to research, develop, manufacture, market or sell the generic drug. Excludes a resolution or settlement that includes no more than: (1) the right to market the generic drug before the expiration of the patent or other exclusivity period, or (2) the waiver of a patent infringement claim for damages. Authorizes the Federal Trade Commission (FTC) to exempt agreements in furtherance of market competition and for the benefit of consumers. Amends the Federal Food, Drug, and Cosmetic Act to deem an applicant to have forfeited market exclusivity if the applicant enters into an agreement that violates this Act. Amends the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 to revise reporting requirements related to agreements between a generic drug applicant and a brand name drug company to include: (1) a description of the subject matter of other agreements between the parties; and (2) a certification that the materials filed represent the complete, final, and exclusive agreement between the parties.

Date: 2012-02-09
Topic: Health (Drug Industry)
Subject: Commerce
Science and Technology Regulatory Relief Act of 2012 - Amends the Federal Food, Drug, and Cosmetic Act to prohibit a state or political subdivision from conducting or requiring an inspection of a factory, warehouse, or establishment in which a drug or device is manufactured, processed, packed, or held by a manufacturer or wholesale distributor for introduction into interstate commerce, or after such introduction, for purposes of verifying compliance with such Act, Public Health Service Act requirements regarding the regulation of biological products, or any similar requirements established pursuant to state law. Makes exceptions for such an inspection if: (1) the state or subdivision makes a determination that a drug or device presents a threat of serious adverse health consequences or death; (2) the Secretary of Health and Human Services (HHS) orders a recall of a drug, biological product, or device manufactured, processed, packed, or held at the factory, warehouse, or establishment; or (3) the Secretary requests or authorizes the state to conduct or require the inspection.

Date: 2012-02-16
Topic: Health (Drug Industry)
Subject: Health
Prescription Drug Labeling Promotion Act of 2012 - Directs the Secretary of Health and Human Services (HHS) to establish a working group to develop best practices on access to prescription drug labeling for the visually impaired. Requires the working group to: (1) include equal representation of consumer and industry advocates; (2) promulgate guidance on best practices for pharmacies to ensure that blind and visually impaired individuals have safe, consistent, reliable, and independent access to the information in the labeling of prescription drugs; (3) consider the use of Braille, specified auditory means, and enhanced visual means to provide such access; and (4) consider whether there are technical, financial, manpower, or other factors that may fundamentally impact the ability of pharmacies with 20 or fewer retail locations to implement the best practices. Directs the Commissioner of Food and Drugs (FDA) to conduct an informational and educational program to inform the public and pharmacists about such guidance and practices. Directs the Comptroller General: (1) 18 months after such guidance and practices are published, to review pharmacy compliance and the extent to which access barriers continue; and (2) by September 30, 2016, to report on such review, including recommendations for reducing such barriers.

Date: 2012-02-24
Topic: Health (Drug Industry)
Subject: Health
Online Pharmacy Safety Act - Amends the the Federal Food, Drug, and Cosmetic Act to permit the dispensing of drugs only pursuant to a "valid prescription" and requires such a prescription to include at least one in-person medical evaluation of the patient by a licensed health care practitioner. Requires the the Secretary of Health and Human Services (HHS) to establish a Registry of Legitimate Online Pharmacy Websites for the purpose of educating consumers and promoting public health and safety. Allows only those pharmacies designated as legitimate by the Secretary on the site. Sets forth criteria for determining the legitimacy of a pharmacy. Requires the Secretary to: (1) engage in a campaign to educate consumers on the availability and use of the Registry to promote public health and safety; and (2) make consumer education materials available, on the Food and Drug Administration's (FDA) website, regarding how to safely purchase drugs over the Internet.

Date: 2012-02-28
Topic: Health (Drug Industry)
Subject: Health
Faster Access to Specialized Treatments Act or FAST Act - Expresses the sense of Congress that the Food and Drug Administration (FDA) should apply specified accelerated approval and the fast track provisions to expedite the development and availability of treatments for serious or life-threatening diseases or conditions while maintaining appropriate safety and effectiveness standards. Amends the Federal Food, Drug, and Cosmetic Act to direct the Secretary of Health and Human Services (HHS), at the request of the sponsor of a new drug, to include as a fast track product a new drug, either alone or in combination with one or more other drugs, that is intended for the treatment of a serious or life-threatening disease or condition. Permits the Secretary to approve an application for approval of a product for a serious or life-threatening disease or condition, including a fast track product, upon a determination that the product has an effect on: (1) a surrogate endpoint that is reasonably likely to predict clinical benefit; or (2) on a clinical endpoint, including an endpoint that can be measured earlier than irreversible morbidity or mortality, that is reasonably likely to predict an effect on irreversible morbidity or mortality or other clinical benefit. Directs the Secretary, in conjunction with other planned reviews of the new drug review process, to contract with an independent entity with expertise in assessing biopharmaceutical development and regulatory review programs to evaluate the FDA's application of the fast track processes on the development and availability of innovative treatments for patients suffering from serious or life-threatening conditions.

Date: 2012-03-05
Topic: Health (Drug Industry)
Subject: Health
Cosmetics Safety Enhancement Act of 2012 - Amends the the Federal Food, Drug, and Cosmetic Act to require the registration of cosmetic products and cosmetic manufacturing facilities, including, for each product: (1) a unique facility identifier, (2) every product's brand name, and (3) product ingredients. Sets registration fees. Requires a cosmetic manufacturer: (1) before the introduction into interstate commerce of a cosmetic product, to establish a file containing scientific evidence substantiating the product's safety; (2) to report any serious adverse event information received that is associated with the use of a cosmetic product; and (3) maintain records concerning any cosmetic product that may be adulterated, misbranded, or otherwise in violation of the Act, including all records relating to cosmetic product safety substantiation or relating to serious adverse event reports. Deems a cosmetic product adulterated if its manufacture, packing, or holding do not conform to current good manufacturing practice regulations. Provides each manufacturer with an opportunity to cease distribution and recall of a cosmetic product if it is determined that there is a reasonable probability that the product is adulterated and the use of, or exposure to, such product will cause serious adverse health consequences or death to humans. Permits the issuance of an order requiring a recall if there is not a voluntary recall of an adulterated product.

Date: 2012-03-26
Topic: Health (Drug Industry)
Subject: Health
Generic Drug Application Review Fairness Act of 2012 - Amends the Federal Food, Drug, and Cosmetic Act to extend from 30 to 60 months after application the period for a first applicant of a generic drug to obtain tentative approval without forfeiting the 180-day exclusivity period with respect to such drug, unless the failure in meeting the extended period is caused by a change in or review of approval requirements. Limits extension coverage to applications filed within 30 months preceding the enactment of this Act. Reduces such extended period by six months per year over a five-year period, beginning on October 1, 2013. Directs the Secretary of Health and Human Services (HHS) to maintain the Office of Generic Drugs as a separate office within the Center for Drug Evaluation and Research of the Food and Drug Administration (FDA).

Date: 2012-03-29
Topic: Health (Drug Industry)
Subject: Health
Patient Safety and Drug Labeling Improvement Act - Amends the Federal Food, Drug, and Cosmetic Act to allow the holder of an approved abbreviated new drug application (generic drug approval) to change the labeling of a drug so approved in the same manner authorized by regulation for the holder of an approved new drug application. Allows conforming changes to be ordered to the labeling of the equivalent listed drug and each drug approved under the abbreviated new drug application process that corresponds to such listed drug.

Date: 2012-04-18
Topic: Health (Drug Industry)
Subject: Health
Cosmetic Safety Amendments Act of 2012 - Amends the Federal Food, Drug, and Cosmetic Act to require the registration of every domestic and foreign establishment engaged in the manufacture of a cosmetic intended to be marketed in the United States with the Secretary of Health and Human Services (HHS). Requires such manufacturers to submit to the Secretary: (1) a cosmetic and ingredient statement for each manufactured cosmetic containing a unique registration number for the manufacturing establishment where the cosmetic is manufactured, the brand name for the cosmetic, the ingredients in the cosmetic, and contact information for individuals responsible for filing and maintaining the cosmetic and ingredient statement; and (2) a report on any serious and unexpected adverse event allegedly associated with the use of a cosmetic product. Requires the Secretary to: (1) establish good manufacturing practices for the manufacture, processing, filling, or packaging of cosmetics; and (2) establish and maintain in the Center for Food Safety and Applied Nutrition of the Food and Drug Administration (FDA) an electronic National Cosmetic Regulatory Databank to hold information pertaining to the regulation of cosmetics. Grants the Secretary authority to review the findings of the Cosmetic Ingredient Review Expert Panel with respect to any cosmetic products. Authorizes the Secretary to: (1) establish a tolerance level for a nonfunctional constituent in a cosmetic product, (2) evaluate the safety of any ingredient in a cosmetic product, and (3) obtain access to and copy records for determining whether a cosmetic product is adulterated and presents a threat of serious adverse health consequences or death to humans. Denies entry into the United States of a cosmetic product if: (1) the importer does not present the unique cosmetic establishment registration number and the unique cosmetic and ingredient statement number, or (2) either of such numbers is not correct.

Date: 2012-04-18
Topic: Health (Drug Industry)
Subject: Commerce
Gluten in Medicine Identification Act of 2012 - Amends the Federal Food, Drug, and Cosmetic Act to deem to be misbranded any drug intended for human use that contains an ingredient (other than a polyol) that constitutes or is derived from a grain or starch-containing ingredient and whose label fails to include a parenthetical statement identifying the source of the ingredient so constituted or derived.

Date: 2012-04-27
Topic: Health (Drug Industry)
Subject: Health
Revises clinical trial registry data bank provisions of the Public Health Service Act to: (1) include a device or drug clinical trial whether or not it results in a positive or negative outcome, and (2) subject clinical trials funded by the Department of Defense (DOD) to requirements to certify information submissions to the Director of the National Institutes of Health (NIH). Restricts funding for a grantee and makes the grantee liable to the United States for repayment of any grant amount provided, if the grantee has not submitted clinical trial information within the 30-day correction period for noncompliance.

Date: 2012-04-27
Topic: Health (Drug Industry)
Subject: Health
Amends the Federal Food, Drug, and Cosmetic Act to direct the Secretary of Health and Human Services (HHS), at the request of the sponsor of a drug, to expedite the drug's development and review if: (1) it is intended, either alone or in combination, to treat a serious life-threatening disease or condition; and (2) preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over existing therapies on one or more clinically significant endpoints. Authorizes the drug's sponsor to request the Secretary to designate the drug as a breakthrough therapy. Requires the Secretary, within 60 days of such request, to determine whether the drug meets such criteria and, if so, make such designation, followed by appropriate actions to expedite its development and review for approval. Requires an annual report from the Secretary to Congress on drugs for which breakthrough designations were requested and approved. Directs the Secretary to issue guidance on implementing requirements with respect to breakthrough therapies and to amend promulgated regulations. Requires the Comptroller General to assess the manner by which the Food and Drug Administration (FDA) has applied the processes established by this Act and their impact on the development and timely availability of innovative treatments for patients affected by serious or life-threatening conditions.

Date: 2012-05-07
Topic: Health (Drug Industry)
Subject: Health
Gray Market Drug Reform and Transparency Act of 2012 - Amends the Federal Food, Drug, and Cosmetic Act to: (1) make it a prohibited act and a misbranding for a wholesale distributor of prescription drugs to purchase or receive a prescription drug from a pharmacy or a pharmacist, (2) require annual reporting by wholesale distributors of prescription drugs, (3) require the Secretary of Health and Human Services (HHS) to establish and maintain a national database of information reported by wholesale distributors of prescription drugs and to require such database to include information on actions taken by states against wholesale distributors (e.g., disciplinary actions and license revocations), (4) require the Secretary to assess and collect fees from wholesale distributors of prescription drugs, and (5) require wholesale distributors of prescription drugs to provide to recipients of a prescription drug in shortage the sales price for such drug at the time of its sale and at the time of any prior sale of such drug when it was in shortage.

Date: 2012-05-22
Topic: Health (Drug Industry)
Subject: Health
Medical Device Patient Safety Act - Directs the Secretary of Health and Human Services (HHS), acting through the Commissioner of Food and Drugs, to establish a program to enhance the oversight by the Food and Drug Administration (FDA) of medical device recalls. Requires the program to routinely and systematically assess: (1) information submitted to the Secretary pursuant to a device recall order issued under the Federal Food, Drug, and Cosmetic Act (FDCA); and (2) information required to be reported by a device manufacturer to the Secretary regarding the manufacturer's correction or removal of a device. Requires the Secretary to use such information to proactively identify strategies for mitigating health risks presented by defective or unsafe devices. Requires such program to be designed to identify such things as recall trends, the causes of recalls, and the time to complete a recall. Requires the Secretary to develop explicit criteria for assessing whether a person subject to a recall order or the manufacturer's reporting requirement has performed an effective correction or removal action. Requires the Secretary to document and publish specified information concerning termination of a recall. Permits the Secretary to conditionally clear for introduction into interstate commerce for commercial distribution a medical device intended for human use if such medical device is cleared pursuant to specified FDCA reporting requirements concerning the introduction of devices into interstate commerce. Permits the Secretary, as part of such conditional clearance, to: (1) impose specified restrictions on the sale, distribution, or use of the device; (2) require specified labeling for the device; and (3) require the maintenance of specified records that enable the FDA to track the device and determine the safety and effectiveness of the device.

Date: 2012-05-30
Topic: Health (Drug Industry)
Subject: Health
Taking Essential Steps for Testing Act of 2012 - Amends the Public Health Service Act to revise sanctions for laboratories that intentionally refer proficiency testing samples required for certification to another laboratory for analysis by: (1) giving the Secretary of Health and Human Services (HHS) discretion to substitute intermediate sanctions for such violations instead of the two-year prohibition against ownership or operation which would otherwise apply, and (2) making the one-year certificate revocation for such a laboratory optional rather than mandatory.

Date: 2012-07-12
Topic: Health (Drug Industry)
Subject: Health
Truth in Trials Act - Amends the federal criminal code to: (1) allow any person on trial for a federal marijuana-related offense to introduce evidence that the alleged marijuana-related activities were performed in compliance with state law regarding the medical use of marijuana, (2) allow an affirmative defense to a marijuana prosecution that the alleged marijuana-related activities complied with state law regarding the medical use of marijuana, (3) limit the criminal liability of persons convicted of federal marijuana-related offenses, (4) require the preservation and return (if a defendant is acquitted) of property seized in connection with a marijuana prosecution, and (5) prohibit the seizure of plants grown or stored under a physician's recommendation or by order of a state or municipal agency in accordance with state law regarding the medical use of marijuana.

Date: 2012-07-17
Topic: Health (Drug Industry)
Subject: Crime and law enforcement
Stop Tampering of Prescription Pills Act of 2012 - Amends the Federal Food, Drug, and Cosmetic Act to prescribe new drug application requirements for tamper-resistant drugs: (1) containing as an active moiety (the part of the drug that makes it work the way it does) a controlled substance classified as opium, an opiate, or a derivative; (2) formulated for oral administration; (3) exhibiting physicochemical properties making them significantly more difficult or ineffective in altering the drug's characteristics for purposes of misuse or abuse; and (4) containing one or more additional ingredients intended to deter abuse through potential pharmacological effects. Requires the Secretary to refuse a new drug application for any new (brand name) drug containing opium, an opiate, or a derivative as an active moiety that is not tamper-resistant if a tamper-resistant drug containing the same active moiety has been approved and has not been discontinued from marketing. Authorizes the Secretary to approve an application failing to meet such requirements, however, if approval is necessary to prevent or alleviate a drug shortage or otherwise address a significant unmet public health need. Requires an abbreviated new (generic) drug application for a tamper-resistant drug to include testing information demonstrating that the generic drug resists manipulation or the effect of manipulation to a degree at least comparable to the listed drug. Authorizes the Secretary to deny approval of a generic application if the listed drug is tamper-resistant and one or more of the generic drug's active moieties differ in any material respect from those of the listed drug. Declares that an approved generic drug shall not be considered bioequivalent to, or as having the same therapeutic effect as, a listed drug if the listed drug becomes tamper-resistant unless and until the generic drug demonstrates that it resists manipulation or the effect of manipulation to a degree at least comparable to the listed drug. Prescribes requirements governing when a drug which is not tamper-resistant may have its approval withdrawn or suspended.

Date: 2012-07-19
Topic: Health (Drug Industry)
Subject: Health
Patient Choice Act of 2012 - Amends the Federal Food, Drug, and Cosmetic Act to authorize provisional approval of fast track products determined by the Secretary of Health and Human Services (HHS) to be adequately safe. Treats provisional approval in the same manner as approval of a drug, except that provisional approval is subject to requirements related to informed consent and continued pursuit of safety and efficacy data for purposes of gaining approval for the drug. Defines the term “adequately safe” to mean that: (1) for at least one population, the risk of death or morbidity caused directly by an adverse effect of the drug is unlikely to be greater than the combined direct and secondary risks of death or morbidity of the disease and existing therapies; or (2) the drug has had a valid marketing authorization for at least four years in specified countries and data adequate for the approval of such marketing authorization has been submitted to the Secretary. Prohibits the Secretary from imposing any requirements for safety studies or data in addition to, or different than, the requirements for studies to establish safety for purposes of Phase 1 (initial introduction of an investigational new drug into humans) or Phase 2 (controlled clinical studies to evaluate the effectiveness of the drug for a particular indication in patients with the disease or condition under study and to determine the common short-term side effects and risks associated with the drug). Applies the provisional approval only to the indication for the drug: (1) which is related to the treatment of the condition with respect to which the drug was designated as a fast track product, and (2) for which the drug is demonstrated to be adequately safety. Prescribes requirements for termination of provisional approval, withdrawal of such approval, and application of market exclusivity to fast-track approval products.

Date: 2012-08-02
Topic: Health (Drug Industry)
Subject: Health
Amends title XVIII (Medicare) of the Social Security Act to authorize direct payment under part B (Supplementary Medical Insurance Benefits for the Aged and Disabled) to a pharmacy for certain covered compound drugs prepared by the pharmacy for a specific beneficiary for the effective use of an implanted infusion pump.

Date: 2012-08-02
Topic: Health (Drug Industry)
Subject: Health
Medicare DMEPOS Market Pricing Program Act of 2012 - Amends part B (Supplementary Medical Insurance) of title XVIII (Medicare) of the Social Security Act to direct the Secretary of Health and Human Services (HHS) to establish a market pricing program for durable medical equipment (DME), prosthetics, orthotics, and supplies (DMEPOS) as a replacement for the competitive acquisition program for DMEPOS, which is hereby terminated. Directs the Secretary to: (1) conduct annual market-priced auctions from among entities supplying market priced items and services in an eligible market area selected in the auction design, (2) establish a lead product for each of specified product categories, and (3) award a contract to any entity in an eligible market area in which an auction is conducted whose bid is below a clearing price equal to the highest cost bid that will meet capacity targets in the market area. Requires the Secretary to contract with an auction expert to assist in, and a market monitor to monitor, the design, development, and functioning of the auction. Adjusts the covered DME item update for 2012 through 2014 and each subsequent year.

Date: 2012-09-21
Topic: Health (Drug Industry)
Subject: Health