Source: http://www.fdalawblog.net/fda_law_blog_hyman_phelps/2010/12/index.html
Timestamp: 2016-07-01 02:33:22
Document Index: 591778008

Matched Legal Cases: ['§505', '§ 101', '§ 414', '§ 206', '§ 402', '§ 403', '§ 402', '§ 306', '§ 505', '§ 505', '§ 355', '§ 505', '§ 505', '§ 505', '§ 505', '§ 1320']

By Kurt R. Karst – Amphastar Pharmaceuticals Inc. (“Amphastar”) has filed with the U.S. District Court for the District of Columbia an Amended Complaint for Declaratory and Injunctive Relief against FDA in Amphastar’s continuing battle to win approval of the company’s long-pending Abbreviated New Drug Application (“ANDA”) for a generic version of sanofi-aventis U.S. L.L.C.’s (“sanofi’s”) blockbuster anti-coagulant drug LOVENOX (enoxaparin sodium injection). The December 22nd amended complaint follows, as we previously reported (here and here), Amphastar’s October 25th Complaint and November 5th Motion for Preliminary Injunction filed against FDA with regard to the Agency’s detention of two entries of semi-purified heparin, the starting material for Enoxaparin Sodium. That issue was resolved after FDA released the raw material. Amphastar’s Amended Complaint, like the company’s original Complaint, alleges violations of the Administrative Procedure Act (“APA”). The Amended Complaint accounts for the factual change arising from FDA’s release of the imported semi-purified heparin raw material and “expounds upon Amphastar’s broader claim of arbitrary and capricious actions by [FDA].” Amphastar alleges a litany of APA violations, including that “FDA’s imposition of immunogenicity testing requirements on enoxaparin ANDAs is beyond the authority of the FDA,” and that “FDA has treated Amphastar disparately from Amphastar’s similarly situated competitors.”
Posted at 05:48 AM in Hatch-Waxman, Prescription Drugs and Biologics | Permalink
Must FDA Treat Similarly-Situated Competitors the Same Way?
In his latest article appearing in FDLI Update, Hyman, Phelps & McNamara, P.C. Director John R. Fleder explores whether the FDA should enforce the FDC Act by giving different treatment to similarly-situated competitors. The article reaches the conclusion that the public is not well served if companies correctly conclude that they are being held to a harsher standard than their competitors. Mr. Fleder explains why the best way to avoid this concern is for FDA to take a nationwide approach to enforcement decisions. He argues that an FDA decision to take an enforcement action must be preceded by an analysis by the agency of whether it is unfairly singling out one competitor for an enforcement action while leaving competitors free from the public stigma of an FDA enforcement action.
By Kurt R. Karst – Another week, another Petition for Writ of Certiorari filed with the U.S. Supreme Court on an issue involving the drug industry. The latest petition comes from Caraco Pharmaceutical Laboratories, Ltd. (“Caraco”) and Sun Pharmaceutical Laboratories, Ltd. (“Sun”) and requests the Court’s review of an April 14, 2010 decision from the Federal Circuit in Novo Nordisk A/S v. Caraco Pharmaceutical Laboratories, Ltd., 601 F.3d 1359 (Fed. Cir. 2010), which addressed whether the patent delisting counterclaim provisions at FDC Act §505(j)(5)(C)(ii)(I), as added by the Medicare Modernization Act, may be used to correct or delete an Orange Book-listed Patent Use Code (“PUC”).
Interest in the Caraco/Sun petition will likely run high and may generate several amicus briefs. GPhA, Mylan, Teva, Apotex, Impax, the National Legislative Association on Prescription Drug Prices, and the Consumers Federation of America filed briefs in the Federal Circuit in support of Caraco/Sun’s rehearing petition. Posted at 10:58 AM in Hatch-Waxman, Prescription Drugs and Biologics | Permalink
By Ricardo Carvajal - Although many of the Food Safety Modernization Act's ("FSMA's") major provisions have a delayed effective date (including the requirement to develop and implement a HACCP plan), some significant provisions will take immediate effect, including: Stronger records access authority (FSMA § 101). FDA gains authority under amended FDC Act § 414(a) to access and copy “all records relating to the manufacture, processing, packing, distribution, receipt, holding, or importation” of a food if FDA believes that there is a reasonable probability that the use of or exposure to the food will cause serious adverse health consequences or death to humans or animals. The provision extends to any other food that FDA reasonably believes is likely to be affected in a similar manner. FDA can access records that the agency needs to determine whether there is “a reasonable probability that the use of or exposure to the food will cause serious adverse health consequences or death to humans or animals.” FDA’s access to records is contingent on “presentation of appropriate credentials and written notice.”
Mandatory recall authority (FSMA § 206). The FDA Commissioner gains authority to order a mandatory recall when the agency determines that there is a reasonable probability that a food other than infant formula is adulterated under FDC Act § 402 or misbranded under § 403(w), and that the use of or exposure to the food will cause serious adverse health consequences or death to humans or animals. FDA must first give the responsible party an opportunity to conduct a voluntary recall. If the responsible party refuses to do so, and the Commissioner issues an order, FDA must give the responsible party an opportunity for an informal hearing within two days of the order’s issuance. Whistleblower protection (FSMA § 402). An employee is protected from retaliation by an employer when that employee (1) provides an employer, the U.S. government, or a state attorney general with information relating to any violation of the FDC Act, (2) testifies or is about to testify in a proceeding concerning such a violation, (3) assists, participates, or is about to assist or participate in such a proceeding, or (4) objects to or refuses to participate in any activity, policy, practice, or assigned task that the employee reasonably believes to be a violation. An employer found to have engaged in retaliation is liable for relief needed to make the employee whole, as well as costs and expenses related to the complaint. Foreign facilities and refusal of inspection (FSMA § 306). An imported food will be refused admission if it is from a foreign establishment to which a U.S. inspector is refused entry for the purpose of conducting an inspection. Entry is deemed refused if the inspector isn’t granted access within 24 hours of requesting entry. Affected firms would do well to review these particular provisions, modify their SOP’s as needed, and train their personnel accordingly.
Posted at 06:54 AM in Foods | Permalink
DEA to Hold Public Meeting on Controlled Substances Disposal Regulations By John A. Gilbert & Karla L. Palmer - The Drug Enforcement Administration announced earlier this week that it is holding a public meeting to discuss with interested persons procedures for the surrender of unwanted controlled substances by ultimate users and long term care facilities. The public input will assist the DEA in the development of regulations to implement the Secure and Responsible Drug Disposal Act of 2010, which President Obama signed into law on October 12, 2010. This Act will allow users to dispose of unwanted controlled substances by delivering them to an authorized entity, and will allow in certain instances long term care facilities to dispose of the unused controlled substances of their residents. The notice further states that the DEA is currently drafting proposed regulations that will permit for the disposal of “unwanted controlled substances by those not registered with the DEA.” The meeting will be held on Wednesday, January 19th and Thursday, January 20, 2011, from 9:00 A.M. until 5:30 P.M. at the Mayflower Renaissance Hotel in Washington, D.C. Check in for the meeting will begin at 8:00 A.M. The meeting is open to all interested persons, including law enforcement, ultimate users (i.e., patients and members of their households), pharmacies, manufacturers, distributors, reverse distributors, or other third parties. Those attending the meeting must register and provide attendee information via email (dea.diversion.policy@usdoj.gov) to the Liaison and Policy Section, Office of Diversion Control, no later than January 12, 2011. The DEA advises that space is limited and thus attendees are encouraged to register early. DEA is permitting requests for limited oral presentations during the meeting; space and time permitting. Those wishing to make an oral presentation should indicate in an email by January 7, 2011, to dea.diversion.policy@usdoj.gov, containing a subject line “Disposal meeting: request to present.” DEA will select speakers based on requests received, and will notify those selected prior to the meeting of approximate starting time, and amount of time available, for the such presentations. More complete details about the registration, speaker and attendance procedures are set forth in the Federal Register notice announcing the meeting. In lieu of attending the open meeting, the DEA also invites interested persons to submit written comments concerning “the most safe and effective method of disposal of controlled substances consistent with the Controlled Substances Act and the Secure and Responsible Drug Disposal Act of 2010.” Comments should be postmarked or received electronically by January 12, 2011. The DEA states that it is seeking comments and oral presentations to address the following “specific concerns”: The process of disposal of unwanted controlled substances could create new and unwanted avenues for diversion. What is the safest manner, in your opinion, to dispose of unwanted controlled substances while preventing diversion?” Please explain why you believe the solution you propose would protect the public health and safety and would curtail diversion. Do you foresee any specific obstacles to the disposal of controlled substances in your community or geographical area? If so, what are they?
Although the meeting will not be webcast, the meeting transcript will be available at the DEA diversion website. Posted at 06:54 AM in Controlled Substances, Drug Enforcement Administration | Permalink
Posted at 02:07 PM in Foods, Foods and Dietary Supplements | Permalink
In a recent citizen petition submitted to FDA, Sandoz Inc. (“Sandoz”) requests from the Agency a written decision that Cobrek Pharmaceuticals, Inc. (“Cobrek”), the alleged “first applicant” for a generic version of HECTOROL (doxercalciferol) Injection, has forfeited 180-day exclusivity eligibility. The Sandoz petition follows another citizen petition, submitted on behalf of Genzyme Corporation (“Genzyme”), concerning the Agency’s ability to approve Cobrek’s pending ANDA No. 90-040 for Doxercalciferol Injection. Genzyme’s petition requested that FDA not approve Cobrek’s ANDA until the expiration of a second, superseding 30-month stay. FDA granted the petition in October. Although the Sandoz petition raises a different set of issues than the Genzyme petition, they arise from the same factual circumstances, and FDA’s reasoning for granting Genzyme’s petition is relevant to Sandoz’s request. As we previously noted, FDA approved HECTOROL (2 mcg/mL, 2 mL) in April 2000 in an ampule presentation under NDA No. 21-027. In December 2008, FDA approved an NDA supplement for HECTOROL for a new injectable formulation (and packaging configuration) in a vial presentation. (The old ampule product is no longer being manufactured and in July 2010, FDA determined that the ampule presentation was not withdrawn from the market for safety or effectiveness reasons.) There are currently three unexpired patents listed in the Orange Book for HECTOROL: U.S. Patent No. 5,602,116 (“the ‘116 patent”), a method-of-use patent, U.S. Patent No. 7,148,211 (“the ‘211 patent”), a formulation (drug product) patent, and U.S. Patent No. 6,903,083 (“the ‘083 patent”), a patent with drug product and drug substance claims, and for which a request for delisting has been submitted to FDA. Cobrek submitted ANDA No. 90-040 to FDA on October 13, 2007 (a Saturday) containing a Paragraph IV certification to the ‘116 and ‘083 patents. According to FDA’s Paragraph IV Certification List, the first ANDA containing a Paragraph IV certification to an Orange Book-listed patent for HECTOROL, 2 mcg/mL, 2 mL ampules, was submitted to FDA on October 15, 2007 (a Monday), thus seemingly making Cobrek a first applicant eligible for 180-day exclusivity. Genzyme timely asserted the ‘116 patent in infringement litigation and triggered a 30-month stay of approval on Cobrek’s ANDA. The ‘211 patent was not listed in the Orange Book for HECTOROL when Cobrek initially submitted its ANDA. Rather, the ‘211 patent was added to the Orange Book after the December 2008 approval of HECTOROL in a vial presentation.
Cobrek has forfeited its 180-day exclusivity rights for a generic version Hectorol® Injection for (at least) two independent reasons. First, Cobrek has amended or withdrawn the Paragraph IV certifications that form the basis for its 180-day exclusivity rights, leading to forfeiture under condition (III). Second and independently, Cobrek has failed to receive tentative approval within 30 months after submission of its ANDA, leading to forfeiture under condition (IV). The references to “(III)” and “(IV)” above are to FDC Act § 505(j)(5)(D)(i)(III) and (IV), which provide that a first applicant forfeits 180-day exclusivity eligibility under the following circumstances:
In other words, according to Sandoz, the “new” Paragraph IV certification does not relate back to the original Paragraph IV certification that formed the basis for a claim to 180-day exclusivity; instead, it supplants the original certification and makes the original certification (and any related claim to 180-day exclusivity) a nullity. It’s an interesting argument, and one that FDA has not yet, to our knowledge, publicly addressed. With respect to FDC Act § 505(j)(5)(D)(i)(IV), Sandoz argues that Cobrek failed to obtain tentative approval within 30 months of ANDA submission (i.e., about April 2010), and that “[n]othing indicates that there was ever any ‘change in or a review of the requirements for [ANDA] approval’ (21 U.S.C. § 355(j)(5)(D)(i)(IV) of a generic ampule version of Hectorol® Injection for which Cobrek submitted its original ANDA,” or for the vial version for which Cobrek is currently seeking ANDA approval. “[I]f anything,” according to Sandoz, “Cobrek’s delay in receiving tentative approval is attributed to its voluntary decision to seek approval for a generic vial version of Hectorol® Injection” (emphasis in original). The three precedents Sandoz identifies in its petition where FDA has identified the exception clause in FDC Act § 505(j)(5)(D)(i)(IV) (i.e., Metaxalone, Imiquimod, and Acarbose) do not provide “any support for the conclusion that an ANDA sponsor’s voluntary decision to reformulate its proposed ANDA product should excuse its failure to obtain tentative approval within 30 months” (emphasis in original), according to the company. More recently, as noted in our 180-Day Exclusivity Tracker, FDA has applied the exception provision in FDC Act § 505(j)(5)(D)(i)(IV) to Zolpidem Tartrate, and to Levocetirizine Dihydrochloride, where FDA determined that “the labeling of the RLD changed after submission of the ANDA” and that “this change was the cause of [ANDA applicant] not obtaining tentative approval of the ANDA within 30 months after the date on which it was filed.”
Sandoz also argues that the Genzyme petition does not excuse Cobrek’s failure to obtain tentative approval, because the petition “has no bearing on Cobrek’s eligibility for tentative approval” (emphasis in original), and could affect only Cobrek’s eligibility for final ANDA approval. By way of background, the 2007 FDA Amendments Act clarified FDC Act § 505(j)(5)(D)(i)(IV), such that if “approval of the [ANDA] was delayed because of a [citizen] petition, the 30-month period under such subsection is deemed to be extended by a period of time equal to the period beginning on the date on which the Secretary received the petition and ending on the date of final agency action on the petition (inclusive of such beginning and ending dates) . . . .” (FDC Act § 505(q)(1)(G)). Posted at 11:00 AM in Hatch-Waxman, Prescription Drugs and Biologics | Permalink
Notorious Affiliate Exclusion Provision of PPACA Repealed
Exclusion from Medicare and Medicaid is a potent weapon used by the government against program-related fraud, but it can be a double edged sword when wielded against drug and medical device companies. Exclusion of a drug or device company means that the federal programs may not reimburse providers for any of the company’s products. This would be a severe detriment to any drug or device company, but it is perhaps equally undesirable for the government, since the exclusion of just one large pharmaceutical company, for example, would deprive Medicare and Medicaid beneficiaries of a multitude of necessary drugs. For this reason, where the HHS Office of the Inspector General ("OIG") has invoked exclusion against drug manufacturers that have pleaded guilty to antikickback law violations, which the OIG is required to do under the mandatory exclusion statute (42 U.S.C. § 1320a-7(a)) , the penalty has been imposed on a shell or defunct affiliate of the drug company, leaving Medicare and Medicaid free to cover the manufacturer’s drugs. During its brief existence, which ended last week, section 6502 of the Patient Protection and Affordable Care Act earned notoriety because it threatened to preclude this practice. Section 6502 added to the Social Security Act a provision requiring, among other things, that State Medicaid agencies exclude from Medicaid any affiliate (or any individual or entity that owned, controlled, or managed an affiliate) of an entity excluded from a Federal health care program. In other words, a drug or device manufacturer’s plea of guilty would necessarily subject the entire company, including all affiliates, to exclusion under Medicaid. The provision would have severely constrained the Department of Justice’s ability to negotiate settlements that would impose appropriate penalties on drug and device manufacturer without harming Medicaid beneficiaries. Fortunately, Congress relatively quickly saw the need for a fix. Section 205(a) of the Medicare and Medicaid Extenders Act of 2010, which was signed into law last Wednesday, December 15, repealed the affiliate exclusion provision. Posted at 08:16 AM in Health Care | Permalink