Source: http://www.fdalawblog.net/fda_law_blog_hyman_phelps/2008/05/index.html
Timestamp: 2017-07-26 22:26:43
Document Index: 168246432

Matched Legal Cases: ['art 15', '§ 417', '§ 301', '§ 1005', '§ 842', '§ 829', '§ 520']

FDA Law Blog: May 2008
FDA issued the proposed rule more than a decade after the Agency first discussed the practical utility, effects, and problems of the pregnancy categories at a Part 15 hearing in September 1997. In the years after the hearing, FDA developed a model pregnancy labeling format, conducted focus group testing on the model, and in June 1999 presented a concept paper to the Pregnancy Labeling Subcommittee of the Reproductive Health Drugs Advisory Committee. Based on the advisory committee’s recommendations, FDA further refined the model format and conducted additional focus group testing. The advisory committee also recommended that FDA revise prescription drug labeling requirements for nursing mothers because of concern that “current labeling on lactation is not informative for a number of reasons, including lack of data and a tendency for clinicians to conclude, based on the current format of the labeling, that they should recommend to their patients that they choose between breast-feeding and taking a drug.” Thereafter, FDA held an advisory committee meeting in September 2000 to discuss potential revisions. The new content requirements of the proposed rule would apply to all applications required to comply with FDA’s January 2006 Physician Labeling Rule, which went into effect on June 30, 2006. This includes: (1) prescription drug products for which an application was approved by FDA between June 30, 2001, and June 30, 2006; (2) prescription drug products for which an application was pending on June 30, 2006; and (3) prescription drug products for which an application was or is submitted anytime on or after June 30, 2006. Below is a copy of the table in FDA’s proposal describing the Agency’s implementation plan.
4 years after the effective date of pregnancy final rule or at time of approval, whichever is later
By Kurt R. Karst Posted at 11:43 AM in Drug Development | Permalink
FDA Delays Implementation of FDAAA Reportable Food Registry until 2009 As we previously reported, the Food and Drug Administration Amendment Act of 2007 (“FDAAA”) mandates that FDA create a Reportable Food Registry (“Registry”). The purpose of the Registry is to facilitate tracking of problems in the food supply, and to allow a more rapid response to such problems by FDA and the food industry. Under new FDC Act § 417, a responsible party must report to FDA the occurrence of a “reportable food,” i.e., a “food . . . for which there is a reasonable probability that the use of, or exposure to, such . . . food will cause serious health consequences or death to humans or animals.” The failure to submit a report is a prohibited act under FDC Act § 301(mm). Although FDAAA requires that FDA create the Registry by Sept. 27, 2008 and that the Agency issue guidance concerning use of the Registry no later than June 27, 2008. FDAAA § 1005(e), (f), FDA announced on May 27, 2008 that implementation of the Registry will be delayed. According to the Agency, because “FDA intends to [use] the business enterprise system,” a system that is under development and will not be operational before Spring 2009, implementation of the Registry will be delayed until at least early 2009. Meanwhile, FDA requests comments concerning the Registry provision in FDAAA. Specifically FDA asks for comment on:
Posted at 12:17 PM in Foods | Permalink
Prior to passage of the Drug Addiction Treatment Act of 2000 (“DATA”), the Controlled Substances Act (“CSA”) and DEA regulations required practitioners to obtain a separate DEA registration as a Narcotic Treatment Program (“NTP”) to conduct maintenance and detoxification treatment using narcotic drugs. DATA amended the CSA by establishing waiver authority for practitioners who dispense or prescribe certain narcotic drugs for maintenance or detoxification treatment. DEA promulgated regulations to permit qualifying physicians to dispense and prescribe schedule III, IV and V narcotic drugs approved by the Food and Drug Administration for maintenance and detoxification for up to 30 patients in their practice without obtaining a second registration as an NTP. The final rule, which takes effect on June 23, 2008, will allow practitioners to treat more patients. This should improve treatment in areas currently underserved for addiction treatment.
Posted at 04:39 AM in Drug Enforcement Administration | Permalink
As in FY 2006, a significant number of final settlement agreements filed in FY 2007 reportedly included both compensation to the generic company and a restriction on generic marketing (79% of these agreements involved “first filer” generics eligible for 180-day exclusivity). However, according to the FTC, unlike the agreements reported on in the Commission’s FY 2006 summary, the agreements filed in FY 2007 concerning restrictions on generic entry “generally did not include some type of side-deal involving elements not directly related to the resolution of the patent dispute between the brand and the generic. Rather, in most of these agreements the compensation to the generic takes the form of the brand’s agreement not to sponsor or compete with an authorized generic for some period of time.” FTC Chairman William E. Kovacic commented that “[t]his report confirms that settlements with potentially anticompetitive arrangements continue to be prevalent. The Commission remains committed to ensuring that brand and generic companies do not use such settlements as a way to deny consumers the benefits of competition.” In March 2006, the FTC proposed a study of the competitive effects of authorized generics. In April 2007, the FTC announced that it was seeking public comment on its proposed information requests to firms in the prescription drug industry. In December 2007, the FTC announced the issuance of those information requests. The FTC has not publicly discussed a timeframe for issuing a study report. By Kurt R. Karst Posted at 04:17 AM in Hatch-Waxman | Permalink
Court Denies DEA Injunction to Suspend Practitioner’s Registration
A U.S. District Court recently denied the Drug Enforcement Administration’s (“DEA’s”) attempt to use an injunction to suspend a physician’s DEA registration. The court noted that the Controlled Substances Act (“CSA”) provides adequate administrative procedures to suspend a DEA registration. The court also denied the government’s motion for summary judgment, determining that the government’s contention that the physician prescribed outside the course of professional practice juxtaposed against the practitioner’s assertion that he followed accepted pain guidelines, present genuine issues of material fact to be decided at trial.
On May 12, 2008, in United States v. Seth Paskon, Judge Carol E. Jackson of the U.S. District Court of the Eastern District of Missouri denied the government’s motions against Seth Paskon, M.D. The government alleged that Dr. Paskon issued medically unnecessary prescriptions for narcotic medications. The government’s civil case against the practitioner under the False Claims Act and the CSA seeking restitution to Medicaid, civil penalties and an injunction against future CSA violations, is set for trial in July. Preliminary Injunction
The government sought injunctive relief directing Dr. Paskon to immediately stop prescribing controlled substances and to surrender his DEA registration. The court concluded that the government failed to meet the burden of showing why the injunction should be issued before trial. The government did not cite, and the court did not find, any cases in which a court limited a physician’s registration prior to disposition of the government’s claims. The court noted that “the CSA provides a comprehensive regime-complete with standards, burdens, and review procedures-pursuant to which DEA may revoke or suspend a physician’s registration.” The court further found that the government did not explain why it did not rely on the CSA’s administrative process to stop Dr. Paskon’s prescribing and terminate his DEA registration. In other words, DEA could have immediately suspended Dr. Paskon’s registration under the CSA's standard and administrative remedies, that is, if his continued registration posed an imminent danger to the public health or safety. Summary Judgment
The government also sought partial summary judgment in the matter. The government alleges that Dr. Paskon violated 21 U.S.C. § 842(a)(1), which provides that it is unlawful for any person to distribute or dispense controlled substances in violation of 21 U.S.C. § 829. Section 829 provides that controlled substances cannot be dispensed without a prescription issued by a practitioner. For prescriptions to be valid, they must “be issued for a legitimate medical purpose by an individual practitioner acting in the usual course of his professional practice.” Judge Jackson cited examples from cases where defendant physicians had acted outside the bounds of “professional practice.” The court distinguished those cases from the case against Dr. Paskon. For example, the court found no evidence that Dr. Paskon, gave inadequate physical examinations, ignored test results, distributed controlled substances away from the office, or demanded cash for prescriptions. The court noted the government provided an expert opinion but lacked evidence from patients and undercover agents to support its contention while Dr. Paskon contended that he followed accepted guidelines, including the World Health Organization’s Pain Ladder, for managing patients with chronic pain. Finding that the record presents genuine disputes of material fact, the court denied the government’s motion for partial summary judgment. By Larry K. Houck
Posted at 10:09 AM in Drug Enforcement Administration | Permalink
Latest FDLI Update Magazine Features Two Articles Written by HPM Attorneys
The latest issue of the Food and Drug Law Institute’s “Update” magazine features articles written by three Hyman, Phelps & McNamara, P.C. attorneys. The first article, titled “FDA Moves Against Marketed Unapproved Human Drugs,” was written by Susan J. Matthees and John R. Fleder and discusses recent FDA actions against companies marketing unapproved drugs. According to the article, the FDA began an enforcement initiative with respect to such drug products in June 2006 to “ensure that all drugs marketed in the United States meet safety, effectiveness, manufacturing, and labeling standards.” Since FDA began this initiative, FDA has publicly taken action with respect to many marketed unapproved drugs, including carbinoxamine, colchincine for injection, hydrocodone, and guaifenesin. Since this article was published, FDA announced a new enforcement action against Scientific Laboratories for manufacturing and distributing several unapproved drugs. The second article, titled “The Pathway to Market for Your Medical Device: A Primer on Obtaining Information from FDA,” was written by Jeffrey K. Shapiro and provides an overview of ways to obtain advance information from FDA on regulatory issues concerning medical device clearance. The article provides a helpful overview of the options available for approaching FDA as well as the pros and cons of each option. Posted at 11:52 AM in Drug Development, Enforcement, Medical Devices | Permalink
FDA Sued After Denying Citizen Petition and Approving Generic EFUDEX Cream ANDA; Agency Will Reconsider ANDA Approval
Valeant Pharmaceuticals International’s (“Valeant’s”) EFUDEX (fluorouracil) Topical Cream, 5%, (also known as 5-FU) is a locally-acting antineoplastic drug product FDA first approved in July 1970 for the topical treatment of multiple actinic or solar keratoses (“AK”). In 1976, FDA approved the drug for a second indication - for the topical treatment of superficial basal cell carcinomas (“sBCC”) when conventional methods are impractical. In December 2004, Valeant submitted a citizen petition to FDA requesting that the Agency not approve any Abbreviated New Drug Application (“ANDA”) for a generic version of EFUDEX Cream unless the application contains data from an adequately designed comparative clinical study conducted in sBCC subjects. Specifically, Valeant argues in the company’s petition that:
The inadequate treatment of sBCC can lead to serious complications for patients, including the growth of their cancer. In that light, . . . is critical that FDA not make assumptions about whether a proposed generic product will be safe and effective in treating sBCC, based on a showing of comparable efficacy in patients with AK. These two conditions occur at different sites of drug action and exhibit different growth patterns. Comparable absorption of a drug to one site of action does not demonstrate comparable absorption to another, more difficult to reach site of action. Similarly, comparable efficacy in an easier to treat condition does not demonstrate comparable efficacy in a more difficult to treat condition. For these reasons, FDA must not allow onto the market generic versions of EfudexÒ Cream until a demonstration of bioequivalence has been made, at a minimum, in patients with sBCC.
On April 11, 2008, FDA denied Valeant's petition and approved Spear Pharmaceuticals, Inc.’s (“Spear’s”) ANDA #77-524 for Fluorouracil Cream, 5%. Citing judicial precedent upholding FDA’s authority to determine the appropriate methods to determine bioequivalence, the Agency states in its petition response that “even when clinical trials are needed, it has not been the Agency’s policy to require that bioequivalence be shown in every indication if drug release from the dosage form and appearance at the or sites of activity has been demonstrated.” Furthermore, FDA concludes that “an AK bioequivalence study is sufficient to establish that the generic topical 5-FU formulation will be available in the epidermis and the upper dermis to act on both AK and sBCC lesions to an extent that is comparable to Efudex Cream.” Two weeks after denying Valeant’s petition and approving Spear’s ANDA, Valeant sued FDA on April 25, 2008 in the U.S. District Court for the Central District of California (Southern Division) for declaratory and injunctive relief pursuant to the Administrative Procedure Act (“APA”). Specifically, Valeant requests in the company’s complaint that the court declare FDA’s decision to approve ANDA #77-524 unlawful and invalid and order FDA to suspend ANDA approval. Valeant also seeks a Temporary Restraining Order (“TRO”) compelling FDA to suspend ANDA approval. (Valiant’s TRO is filed under seal.) FDA, as the Agency did in its petition response, argues in its TRO opposition memorandum that the Agency has broad discretion to determine the appropriate requirements for a generic applicant to demonstrate bioequivalence. Furthermore, FDA argues that its petition decision and ANDA approval are entitled to deference under the APA, and that Valeant has not met the requirements to support a TRO. Spear, which has intervened in the case, makes similar arguments in its TRO opposition papers and also alleges that Valiant’s lawsuit and citizen petition are merely tactics to block or delay generic competition. (Valiant’s petition was submitted to FDA prior to the enactment of the FDA Amendments Act, which amended the FDC Act to require FDA to take final action on certain petitions that would delay generic drug approval within 180 days after petition submission.)
After submitting its TRO opposition papers, FDA became aware of an “administrative issue” and “an additional issue concerning Spear’s ANDA which, in the agency’s judgment, necessitates administrative reconsideration of the ANDA approval,” and requested that the court stay proceedings and refer the matter to FDA. On May 14, 2008, FDA issued an “Administrative Reconsideration and Stay of Action” to Spears staying the approval of ANDA #77-524, and the company has since suspended selling the drug product. FDA hopes to complete its review of these issues and the administrative reconsideration process by May 30, 2008. Until then, further litigation is stayed.
It is unclear what, exactly, the two issues are that led FDA to suspend the approval of ANDA #77-524. According to FDA’s Orange Book, EFUDEX Cream, 5%, is not subject to any period of patent or non-patent market exclusivity, so the administrative and scientific issues referred to by FDA would not appear to involve such issues. We will update you as we learn additional information.
By Kurt R. Karst Posted at 05:22 AM in Hatch-Waxman | Permalink
FDA to Hold Public Meeting on the Evaluation of Trade Names
FDA recently announced that on June 5 and 6, 2008, the Center for Drug Evaluation and Research and the Center for Biologics Evaluation and Research will hold a public meeting to discuss the Agency’s plans to launch a pilot program on the testing and review of proprietary names and the issuance of a concept paper that will describe the logistics of the pilot program, recommendations for implementing a proprietary name review, and the proposed review of submissions made under the pilot program. The pilot program will allow participating companies to submit data generated from their own testing and evaluation of proposed proprietary product names. FDA expects to issue the concept paper by the end of Fiscal Year (“FY”) 2008 and begin enrollment in the pilot program in FY 2009.
The pilot program and concept paper are intended to increase the transparency of FDA’s review process of proprietary names and to decrease the risk of medication errors. Currently, FDA reviews proprietary names to determine any promotional or safety issues. For example, FDA considers whether a proposed name overstates the efficacy of the drug product, minimizes the drug product’s risks, or broadens its indications. FDA also considers whether the name is spelled similarly or sounds similar to another marketed product or could otherwise cause confusion, such as having similar abbreviations. The current safety review expands the entire medication process, taking into consideration, for example, errors that could arise during the procurement, prescribing, ordering, dispensing, and administration of a drug.
Under the performance goals FDA agreed to as part of the recent reauthorization of the Prescription Drug User Fee Act (i.e., PDUFA IV), the Agency committed to implement various measures with respect to proprietary name review in an attempt to reduce medication errors. These measures include meeting certain proprietary name review performance goals (beginning in FY 2009) during the IND and NDA/BLA review phases, publishing guidance and policy procedures on proprietary name review and best practices, developing and implementing a pilot program “to enable pharmaceutical firms participating in the pilot to evaluate proposed proprietary names and submit the data generated from those evaluations to the FDA for review,” and “exploring the possibility of ‘reserving’ proprietary names for companies once the names have been tentatively accepted by the Agency.” FDA’s June 2008 meeting is part of the Agency’s efforts to meet these goals. FDA’s efforts also respond to calls for more industry involvement in the proprietary name testing process, including requests made in reports by the Institute of Medicine in 2006 and 1999 and recommendations made by the Health and Human Services Advisory Committee on Regulatory Reform in November 2002. During the meeting, FDA plans to discuss the following key issues: (1) best practices in safety and promotional testing of proprietary names; (2) testing procedures that should be used and data that should be submitted by those participating in the pilot; (3) standardization of testing; (4) criteria to consider in evaluating the testing and data submitted; (5) the structure and evaluation of the pilot program; and (6) any public health concerns raised by the pilot program. FDA will use the information gathered from the meeting and from comments submitted to the docket to develop the concept paper and the pilot program. The meeting will be held from 8:30 a.m. to 5:00 p.m. each day at the Crowne Plaza Hotel in Silver Spring, Maryland. Information on meeting attendance and registration is provided in FDA’s Federal Register notice announcing the meeting. Written comments regarding the concept paper and pilot program must be submitted by July 6, 2008 to the Division of Dockets Management or electronically at www.regulations.gov. By Carrie S. Martin
Posted at 04:35 PM in Drug Development | Permalink
WHO Set to Consider Dextromethorphan Scheduling in April 2009
Dextromethorphan is an important ingredient in many cough/cold medications. The World Health Organization (“WHO”) is considering whether to schedule dextromethorphan as a controlled substance under the international conventions of the United Nations system. If that occurs, then the U.S. government will be obligated to schedule dextromethorphan under the Controlled Substances Act, an action that could dramatically affect the manufacturing, distribution, and availability of medicines containing the substance.
At the next meeting of WHO’s Expert Committee on Drug Dependence, dextromethorphan is scheduled to be given a “pre-review.” That meeting will occur in April, 2009. If, following this “pre-review,” the drug is recommended for “critical review,” the committee will at the meeting thereafter determine whether to recommend scheduling.
Space does not permit a full description of the WHO scheduling process. If this issue is of interest, please call Jim Phelps or John Gilbert at Hyman, Phelps & McNamara, P.C. Also, please see our previous post, which, among other things, provides some background information on the WHO scheduling process.
Posted at 08:49 PM in Drug Enforcement Administration | Permalink
On May 1, 2008, a federal judge in the Middle District of Florida brought some measure of closure to FDA’s more than six years of attempts to regulate a self-identified custom device manufacturer. In his May 1st order, Judge G. Kendall Sharp mostly sided with Endotec, Inc., and the two individual defendants, Michael J. Pappas, Endotec’s co-owner and president, and Dr. Frederick F. Buechel, Endotec’s other co-owner and medical director. Since at least its March 15, 2002 Warning Letter to Endotec, FDA has maintained that Endotec’s devices were not custom devices under FDC Act § 520(b). While the Judge agreed with FDA with respect to the knee devices manufactured by Endotec, he refused to grant FDA’s request for disgorgement of profits even with respect to these devices. Judge Sharp found, as a conclusion of law, that Endotec’s ankle and TMJ devices were custom devices, and thus not adulterated or misbranded.
The court, without the deference to agency expertise and regulations that one often sees in challenges to FDA decisions, stated that an FDA witness’ “interpretation of ‘custom device’ is so narrow as to make the definition useless.” FDA typically takes the position that a device being studied under an investigational device exemption (“IDE”) cannot also qualify as a custom device, because it is capable of being studied. The court concluded, however, that even though Endotec had an approved IDE for the Buechel-Pappas Ankle (“B-P Ankle”), the ankle devices at issue were custom devices. The court so held based on testimony from Endotec that the “surgeon specials” although “similar to the standardized B-P Ankle that was being studied under the IDE,” were custom devices and not “‘merely a variation’ within a range.”
While not strictly relevant to its analysis, the court’s decision notes as several points that there is no allegation that these devices are unsafe or ineffective. Additionally, while recognizing that it is up to Congress to improve the law, the court suggested that FDA’s premarket approval (“PMA”) and 510(k) processes were unduly burdensome and time-consuming and were preventing technological advances from reaching patients. The case was not a total loss for FDA. As noted above, the court did find that Endotec’s knee devices were adulterated and enjoined their manufacture and distribution. In addition, with respect to the ankle devices that the court found to be custom devices, the defendants are enjoined “from advertising the B-P Ankle or any custom ankle device through websites, in professional journals, at professional conferences, or by any other means, thereby essentially incorporating the statutory and regulatory restrictions into a court order. FDA has 60 days to appeal from the court’s order to the Eleventh Circuit. Aside from an appeal, it is uncertain how this case may affect FDA’s regulation of custom devices. The court did not hold or suggest that FDA’s definition of custom device is invalid. Nevertheless, the decision demonstrates that for device manufacturers who may disagree with FDA’s application of the custom device exemption, FDA’s enforcement position is not necessarily the final word. By J.P. Ellison
Posted at 04:29 AM in Enforcement, Medical Devices | Permalink