January 31, 2013

Gilead Petitions FDA for Revised NCE Policy for Combination Drugs

Treatment for HIV/AIDS generally requires patients to take a large number of drugs. For HIV therapy, for example, at least three active drugs, usually from two different classes are required to suppress the virus, allow recovery of the immune system, and reduce the emergence of HIV resistance. As a consequence, medicines are being developed that combine these drugs into fixed dosages, thus providing a combination therapy that simplifies dosing and helps patient compliance.

Gilead Citizen Petition by FDA Lawyers Blog

Gilead Sciences ("Gilead") has developed a new fixed dose combination ("FDC"), STRIBILD®, which contains four distinct drugs: elvitegravir ("EVG"), cobicistat ("COBI") , emtricitabine ("FTC") and tenofovir disoproxil fumarate ("TDF"). EVG and COBI have not been approved before by FDA but both FTC and TDF have been.

Generally when a drug containing a new active ingredient is approved for the first time by FDA, it is considered a new chemical entity ("NCE"), which enables it to receive 5 years of market exclusivity, preventing third parties referencing that drug for their own applications for 5 years (or 4 years if their application includes a Paragraph IV certification / patent challenge).

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January 30, 2013

Biotechnology Innovators Lobby Congress to Restrict Use of Biosimilars

Thumbnail image for Thumbnail image for Thumbnail image for Thumbnail image for dna.jpgOn January 28, The New York Times reported that biotechnology companies are actively lobbying state legislatures to limit access to biosimilar versions, i.e., "highly similar" versions of previously-approved, innovator biological products ("biologics"). According to the author, Andrew Pollack, Amgen and Genentech are proposing bills that would make it more difficult for pharmacists to substitute biosimilar versions for the innovator's products, unless FDA determines that a particular biosimilar version is "interchangeable" with the innovator's product.

For instance, the Virginia House of Delegates reportedly already passed such a bill last week by a 91-to-6 vote. Other bills in the works require patient consent for substitution, pharmacist notification of the patient's physician if a switch is made, and for both the pharmacist and patient's physician to maintain records of any such substitutions for years.

The Generic Pharmaceutical Association ("GPhA") and insurers generally accept that biosimilar substitution for a biologic should follow similar methods as with drugs only if deemed interchangeable by FDA but find that many of the bills go further to discourage use of biosimilars. "All of these things are put in there for a chilling effect on these biosimilars," commented Brynna M. Clark, Director of State Affairs for GPhA, adding that many of the limits "don't sound too onerous but undermine confidence in these drugs and are burdensome." GPhA and insurers would prefer that legislatures leave biosimilar regulation to FDA, which has been entrusted with using its regulatory prowess to determine the necessary requirements for biosimilars and "interchangeable" biosimilars, as well as when to waive those requirements based on what is know about a particular biosimilar product.

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January 28, 2013

NYSBA's Annual Meeting for the Food, Drug and Cosmetic Law Section Draws a Crowd

eye.jpgOn January 24 to a packed house, the Food, Drug and Cosmetic Law Section of the New York State Bar held its annual meeting. This year, the agenda featured presentations on medical devices, a Supreme Court update, an in-house/outside counsel panel to discuss effective relations for FDA/regulatory advice, a discussion of the Federal Sunshine Act, and "A View from the Inside" retrospective of some hot issues at FDA from a recent high-level official at FDA, including the new food and pharmacy initiatives under development.

In the Supreme Court update called "Pivotal Court Cases for FDA Practitioners 2012-2013 Updates", FLH Partner Brian J. Malkin, spoke on two cases to watch in the first quarter of 2013, Mutual Pharm. Co., Inc. v. Bartlett , No. 12-142 (U.S., cert. granted Nov. 30, 2012, argument scheduled Mar. 19, 2013) and Bowman v. Monsanto Co., No. 11-796 (U.S., cert. granted Oct. 5, 2012, argument scheduled Feb. 19, 2013). The question presented in Mutual v. Bartlett is:

Whether the First Circuit erred when it created a circuit split and held--in clear conflict with this Court's decisions in Pliva, Inc. v. Mensing, 131 S. Ct. 2567 (2011); Riegel v. Medtronic, Inc., 552 U.S. 312 (2008); and Cipollone v. Liggett Group, Inc., 505 U.S. 504 (1992)--that federal law does not preempt state law design-defect claims targeting generic pharmaceutical products because the conceded conflict between such claims and the federal laws governing generic pharmaceutical design allegedly can be avoided if the makers of generic pharmaceuticals simply stop making their products.

Bowman v. Monsanto is a case that my firm, Frommer Lawrence & Haug LLP, is arguing on behalf of petitioner Bowman, where the question presented is:

Patent exhaustion delimits rights of patent holders by eliminating the right to control or prohibit use of the invention after an authorized sale. In this case, the Federal Circuit refused to find exhaustion where a farmer used seeds purchased in an authorized sale for their natural and foreseeable purpose--namely, for planting. The question presented is: Whether the Federal Circuit erred by (1) refusing to find patent exhaustion in patented seeds even after an authorized sale and by (2) creating an exception to the doctrine of patent exhaustion for self-replicating technologies?

Mr. Malkin's summaries of these two cases may be found here. His presentation for these two cases, including topics for consideration by the Food, Drug, and Cosmetic Section may be found here.

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January 23, 2013

Combination Product Final Rule and Guidance Issued to Streamline CGMP and Supplements

Thumbnail image for 3699948229_d7732f8df0_o.jpgYesterday, FDA issued two new items to help clarify combination products: 1) a Final Rule published in the Federal Register entitled, "Current Good Manufacturing Practice Requirements for Combination Products" and 2) a Draft Guidance entitled, "Guidance for Industry and FDA Staff:
Submissions for Postapproval Modifications to a Combination Product Approved Under a BLA, NDA, or PMA", also announced in the Federal Register.

The Final Rule is intended to clarify which good manufacturing practice ("CGMP") requirements apply when drugs, devices, and biological products are combined to create combination products. The Rule also provides a mechanism that FDA describes as "transparent and streamlined regulatory framework" for companies to use when demonstrating compliance with CGMP requirements for "single-entity" and "co-packaged" combination products. "Single-entity" combination products are two or more regulated components, e.g., drug/device, biologic/device, drug/biologic/device, which are physically, chemically, or otherwise combined or mixed and produced as a single-entity. Two or more separate products packaged together in a single package or as a unit and comprised of two or more regulated products is a "co-packaged" combination product. The Final Rules started as a Draft Guidance announced on October 4, 2004 (69 FR 59239), entitled "Current Good Manufacturing Practices for Combination Products." Based on comments and FDA's own internal review, FDA decided that "rulemaking was warranted" and issued Proposed Rules on September 23, 2009 (74 FR 48423).

The concept behind the CGMP Rule is simple for parts that are separately manufactured and marketed: each of the constituent parts of a combination product are subject only to the CGMP regulations applicable to that part, e.g., drug, biologic, or device. The two categories of combination products mentioned above, however, "single-entity" and "co-packaged" are slightly different due to the possibility for overlapping CGMP requirements for the different regulated components. Companies have two basic options for these types of products: 1) demonstrate compliance with the specifics of all CGMPs to each of the parts, or 2) demonstrate compliance with the specifics of either the drug CGMPs at 21 C.F.R. Parts 210 and 211 or the quality system ("QS") regulation at 21 C.F.R. Part 820 rather than both, for drug/devices under certain conditions. For combination products including biologics, the specific regulations are 21 C.F.R. parts 600 through 680, and for product including any human cell, tissue, and cellular tissue-based products, the regulations are 21 C.F.R. Part 1271.

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January 22, 2013

Kozlowski, Joneckis, and Shuren Provide FDA Overview of Biotechnology Issues

Thumbnail image for DNA2.jpgToday, FDA Center Officials from the Center for Drug Evaluation and Research ("CDER"), the Center for Biologics Evaluation and Research ("CBER"), and the Center for Devices and Radiologic Health ("CDRH") provided an overview of upcoming biotechnology issues to the TechCouncil of Maryland, MdBio / MdTech at a full house in Bethesda, Maryland.

Representing CDER, Steven Kozlowski, M.D., Director of the Office of Biotechnology Products, Office of Pharmaceutical Science, said that his Office, which regulates monoclonal antibodies and therapeutic proteins, has been primarily concerned with the mechanism of action and potential for immunogenicity for these products. Describing a triad of research and development, application review, and inspections, Kozlowksi described his Office's challenges as often concerning "too many notes" for biologics--discerning which notes matter, given that technology has come up with ways to further characterize products and reveal more notes.

Kozlowski said that through the life cycle continuum of a biotechnology product, it is the applicant's responsibility to make sure that biotechnology products are manufactured using the best available science to prevent issues such as viral contamination that can cause plant shut downs and shortages. To help prevent such issues, FDA is further integrating its review and compliance functions, in part with the use of new user fee authorizations. For biosimilars, FDA recognizes the studies necessary for approval will depend on the analytics and results from those analytics, comparing the innovator's product to the proposed biosimilar product.

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January 18, 2013

Safe Harbor Provision Case Not Selected for Supreme Court Review

Thumbnail image for Thumbnail image for supremecourt.pngEarlier this week, the U.S. Supreme Court denied GlaxoSmithKline's certiorari petition in a case that would have helped clarify the scope of 35 U.S.C. § 271(e)'s safe-harbor provision. The issue facing the Court was whether section 271(e)(1) applies to postmarketing activity as well as premarketing activity.

Section 271(e), which states that it is not an act of infringement to make, use, offer to sell, or sell a patented invention "solely for uses reasonably related to the development and submission of information under [federal drug laws]," does not include a time limitation. The question about timing was highlighted in two recent Federal Circuit cases. In Classen Immunotherapies, Inc. v. Biogen Idec, 659 F.3d 1057 (Fed. Cir. 2011), the Federal Circuit explained that "§ 271(e)(1) is directed to premarketing approval of generic counterparts before patent expiration." Last year, however, a different panel of judges in Momenta Pharmaceuticals, Inc. v. Amphastar Pharmaceuticals, Inc., 686 F.3d 1348 (Fed. Cir. 2012) held that post-approval studies performed for the FDA fall within § 271(e)(1)'s safe harbor and explained that Classen held that 271(e)(1) "does not apply to information that may be routinely reported to the FDA, long after marketing approval has been obtained."

As previously blogged on here, the Solicitor General had urged the Supreme Court to deny GSK's petition in the Classen case. Despite a belief that the Federal Circuit erred in Classen, United States Solicitor General Donald Verrilli offered the following reasons why the Supreme Court should deny certiorari: (1) the Federal Circuit's Momenta decision sufficiently clarified and narrowed the Classen holding; (2) it was unclear whether the safe harbor applied to the types of patents at issue in the Classen case; and (3) the petitioners were not entitled to the safe harbor protection regardless of the Supreme Court's interpretation of the provision.

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January 17, 2013

Generic Drug Fees for Finished Dosage Forms and Active Pharmaceutical Ingredient Facilities Announced - GDUFA FY2013 Summary

<Thumbnail image for Thumbnail image for Thumbnail image for drugmoney.jpegOn January 17, FDA published in the Federal Register the finished dosage form ("FDF") and active pharmaceutical ingredient ("API") facility fees for fiscal year 2013 ("FY2013") (October 1, 2012 to September 30, 2013). FDA's most recent publication rounds out the list of new user fees associated with generic drugs filed as abbreviated new drug applications ("ANDAs"), which were authorized by the Generic Drug User Fee Amendments of 2012 ("GDUFA") and enacted by the Food and Drug Administration Safety and Innovation Act of 2012.

GDUFA authorizes FDA to assess and collect fees for ANDAs and certain supplements associated with human generic drug products, ANDAs in the backlog as of October 1, 2012, finished dosage form ("FDF") and active pharmaceutical ingredient ("API") facilities, and on Type II drug master files ("DMF") to be made available to reference. FDA has been staggering its publication of these rates for FY2013 with the FDF and API facility fees as being the latest in the series.

To summarize these fees for FY2013:

(1) ANDA and Prior Approval Supplement ("PAS") fees were published in the Federal Register on October 25, 2012 as $51,520 for an ANDA and $25,760 for a PAS. If an ANDA is refused to file and the refusal is not related to a failure to pay fees, the applicant will receive 75% of this fee amount. If an ANDA fails to pay fees within 20 calendar days of submission, the application is deemed incomplete and will be "received" only after payment in full is received. User fees are required for all PASs, including labeling and microbiology that require prior approval under FDA regulations.

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January 16, 2013

FLH Partner Malkin Quoted in FDAnews Article on Unusual Alabama Supreme Court Ruling Holding Branded Company Liable for Generic Drug

alabama.jpgOn January 16, 2013, FLH Partner Brian J. Malkin was quoted in FDAnews article: "Alabama Supreme Court: Brand Drugmakers Can Be Held Liable for Generic-Drug Labeling". The Alabama Supreme Court recently held that Pfizer Inc. ("Pfizer") could be sued for injury caused by a generic version of its drug. FDAnews asked Mr. Malkin how this could affect branded drug manufacturers makers and whether this decision would contradict federal laws and court rulings. Below is an excerpt from that story:

The Alabama court decision raises the question of whether states or the federal government should have had jurisdiction over the matter, Brian Malkin, a Partner at Frommer Lawrence & Haug told DID.
"If it is fraud, it is fraud on a national level so you would think the case should have gone to the FDA," Malkin said. He has noticed a tension between state-specific and FDA authority in this arena and has noted a couple of cases where states seem to be taking on areas that are traditionally in the FDA's realm. The Mutual v. Bartlett generic preemption case set to be heard by the Supreme Court this spring also began at the state court level, Malkin said (DID, Dec. 3, 2012).

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January 14, 2013

FLH Partner Brian J. Malkin Quoted in Opioid Generics Article in FDAnews

crush.jpgOn January 14, FLH Partner Brian J. Malkin was quoted in the FDAnews article: "Hamburg: FDA Can Require Opioid Generics to Duplicate Brands' Abuse-Deterrent Properties". The article concerned a recent letter from FDA Commissioner Margaret A. Hamburg, M.D., to Representative Fed Upton (R-Michigan), Chairman, Committee on Energy and Commerce, where she wrote regarding Upton's and Sen. Tom Coburn (R-Oklahoma)'s concerns regarding non-tamper-resistant opioids being approved by FDA to enter the market. Mr. Malkin was quoted in a previous FDAnews article concerning the letter on January 2, entitled "Legislators Press FDA on Safety of Opioid Generics" where the article stated: "The FDA may be wary of siding with petitions such as Endo's[regarding requiring generic versions of its Opana ER® to be crush resistant], which could create barriers for generic drugs, Brian Malkin a partner at Frommer Lawrence & Haug, told DID. He believes the FDA is unlikely to determine Endo's non-crush-resistant formulations was withdrawn for safety reasons."

After correcting Upton that in this context, "tamper-resistant" actually meant "abuse-deterrent", Hamburg used the stock phrase "Please be assured that HHS and FDA share your concerns, and those of your constituents, regarding prescription drug abuse, including the abuse of opioid analgesics." The letter continues, "As part of our ongoing mission to protect public health, FDA has concluded that if FDA determines that a formulation of a product significantly deters abuse, we have legal authority, under the drug approval and drug safety provisions of the Federal Food, Drug, and Cosmetic Act, to require generic versions of that product to have abuse-deterrent formulations as well."

Further, Hamburg noted that FDA could suspect approval without notice and opportunity for a hearing if the Secretary determines "that there is an imminent hazard to the public health" and an opportunity for an expedited hearing in the future. FDA, however, has only used this "imminent hazard authority" once, in July 1977, to suspend new drug approvals for phenformin hydrochloride, a diabetes drug. Hamburg also indicated that FDA would be publishing guidance on the development of abuse-deterrent products, which it did publish the following day.

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January 8, 2013

Stem Cell Research Funding Case Rejected by Supreme Court to Hear

Stem Cell.jpgThis Monday, the U.S. Supreme Court announced that it will not review a challenge to federal funding of human embryonic stem-cell research. By rejecting the petition from a pair of scientists opposing such funding, the Court gave the green light for controversial embryo-based studies to move forward.

Scientists James L. Sherley and Theresa Deisher sued the United States Department of Health and Human Services ("HHS") and the National Institutes of Health ("NIH") in 2009, challenging NIH guidelines related to human-stem cell research promulgated pursuant to Executive Order 13,505. E.O. 13,505 was signed by President Barack Obama in March 2009 with the aim "to expand NIH support for the exploration of human stem cell research." The order loosened limitations imposed by the previous administration on the use of federal tax dollars for embryonic stem cell research and overturned an order barring NIH from conducting research on embryonic stem cells beyond the 60 cell lines then in existence. In addition, it directed NIH to review its guidelines regarding stem-cell research.

Sherley and Deisher-both adult stem-cell researchers who do not conduct research on human embryos or embryonic stem cells-challenged the Guidelines on the grounds that: (1) NIH refused to address comments submitted in response to the draft version, in violation of the Administrative Procedure Act and (2) they violate the Dickey-Wicker Amendment. The Dickey-Wicker Amendment is an appropriations rider, included in every HHS appropriations bill since 1996, prohibiting the use of federal funds for "the creation of human embryo or embryos for research purposes" and "research in which human embryo or embryos are destroyed, discarded, or knowingly subjected to risk of injury or death greater than that allowed for research on fetuses in utero under [other federal regulations]." The final NIH Guidelines, published on July 7, 2009, authorized federal funding of research using live human embryos that were created "for reproductive purposes" (i.e., in vitro fertilization) but are "no longer needed for [that] purpose."

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January 4, 2013

Safety Reporting Requirements Explained -- More Targeted Reporting Emphasized

3699948229_d7732f8df0_o.jpgTowards the end of last year, FDA added two new final guidances related to the safety reporting requirements for investigational new drug exemptions ("INDs") and bioavailability and bioequivalence ("BA/BE") studies entitled: Guidance for Industry and Investigators: Safety Reporting Requirements for INDs and BA/BE Studies and Guidance for Industry and Investigators: Safety Reporting Requirements for INDs and BA/BE Studies-Small Entity Compliance Guide. These guidances are intended to explain final rules published on September 29, 2010 that amended the IND safety reporting requirements under 21 C.F.R. Part 312 and added safety reporting requirements for individuals conducting BA/BE studies under 21 C.F.R. Part 320. We blogged on that development then.

A key focus of the new regulations was to add clarifying definitions to certain terms, "adverse event", "suspected adverse reaction", "unexpected" adverse event or reaction, "serious" adverse event or reaction, and "life-threatening", as well as further define reporting requirements. According to the main Guidance (not the one for small entities), sponsors frequently took a broad reading of the phrase "associated with the use of the drug" in the context of the former 21 C.F.R. § 312.32(a), which stated, "there is a reasonable possibility that the experience may have been caused by the drug." With this broad reading, the Guidance continues, "sponsors frequently reported, as individual cases, serious adverse experiences for which there was little reason to believe that the drug caused the event." The Guidance includes three examples of overzealous reporting, including reporting adverse experiences that were manifestations of the underlying disease, common occurrences in the study population independent of drug exposure, or study endpoints. FDA described these types of reporting as a drain on agency resources and "uninformative when reported as single events (i.e., without a comparison of the incidence of the event in treated and untreated subjects), they do not contribute meaningfully to the developing safety profile of an investigational drug or to human subject protection."

Interestingly, this appears to be somewhat of a departure from how FDA had enforced its reporting regulations on clinical investigators. Shortly after I first joined FDA in the 1990s, I was involved in a clinical investigator disqualification proceeding that resulted in a clinical investor being disqualified from further clinical studies because, among other things, he had not timely or accurately reported certain adverse events. While the Presiding Officer took into account that many of the patients had underlying conditions prior to the experimental therapy, the Center for Drug Evaluation and Research ("CDER's") approach appeared to focus on the need for the investigator to report all adverse event associated with the therapy. In this case, the therapy had to do with infusing a drug with a catheter to help dissolve gall bladder and common bile duct stones, which the CDER described as a drug/device. The investigator admitted that he had not immediately reported certain events that occurred as a result of the catheter insertion (most likely not due to the drug) or the patient's underlying conditions, because in his opinion, they were not associated with the drug therapy. At that time, CDER took the approach that the investigator's opinion was irrelevant, because the adverse events were at least temporally associated with the drug/device and therefore had to be timely reported.

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January 2, 2013

FLH Partner Brian J. Malkin Quoted in FDAnews Year End Wrap-Up on Generics

drugs.jpgFDA Partner Brian J Malkin helped suggest key topics for and was quoted in an FDAnews article published on January 2, 2013, entitled "Landmark Year for Generics Cues Big Changes, Rulings in 2013". First, Mr. Malkin was quoted in a section regarding risk evaluation mitigation strategies. Here, FDAnews wrote:

...But generic-makers failed to win a key provision that would have allowed access to hard-to-obtain products covered under risk evaluation and mitigation strategies (REMS).

... The loss of the REMS provision may be mitigated by the FDA's move to more classwide REMS, a strategy that could keep brand drugmakers from using patents on the plans to block generic competition, Brian Malkin, a partner at Frommer Lawrence & Haug, said.

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December 18, 2012

Solicitor General Urges Supreme Court to Pass on Classen

Thumbnail image for supremecourt.pngThe Solicitor General has urged the U.S. Supreme Court to deny GlaxoSmithKline's ("GSK's") pending certiorari petition in GlaxoSmithKline v. Classen Immunotherapies, Inc., case number 11-1078 The issue facing the Supreme Court should it grant GSK's petition is whether the Federal Circuit correctly interpreted 35 U.S.C. § 271(e)(1)'s safe harbor as applying to only pre-market approval of generic counterparts. In its amicus brief submitted late last week, the Solicitor General explained that there is no need to clarify the safe harbor provision and voiced concerns that the Classen case would not be the proper vehicle to do so should the Supreme Court feel the need.

The dispute between GSK and Classen involves three patents, U.S. Patent Nos. 6,638,739, 6,420,139, and 5,723,283, which relate to methods of optimizing vaccine immunization schedules to decrease the risk of developing chronic immune-mediated disorders. Classen sued a number of defendants, including GSK, alleging infringement of its patents through various vaccination research projects. GSK's allegedly infringing activities related to its participation in a government study that evaluated a suggested association between the timing of childhood vaccinations and the risk of developing type 1 diabetes. GSK argued, and the district court agreed, that such activity was within section 271(e)(1)'s safe harbor because the information was ultimately submitted to FDA. On appeal, the Federal Circuit reversed, holding that section 271(e)(1) "does not apply to information that may be routinely reported to the FDA, long after marketing approval has been obtained." Classen Immunotherapies, Inc. v. Biogen Idec at 1070. The Federal Circuit further explained, "§ 271(e)(1) is directed to premarketing approval of generic counterparts before patent expiration." Id. at 1071.

In the amicus brief, United States Solicitor General Donald Verrilli expressed his belief that the Federal Circuit's interpretation of § 271(e)(1) in Classen was incorrect. 35 U.S.C. 271(e)(1) reads:

It shall not be an act of infringement to make, use, offer to sell, or sell within the United States or import into the United States a patented invention . . . solely for uses reasonably related to the development and submission of information under a Federal law which regulates the manufacture, use, or sale of drugs or veterinary biological products.

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December 14, 2012

European Unified Patent Approach Approved

Thumbnail image for Thumbnail image for Thumbnail image for european commission.jpegThis Tuesday, the European Parliament approved European Union ("EU") regulations creating a European patent with unitary effect ("unitary patent") and setting forth related language translation requirements. The unitary patent, granted by the European Patent Office ("EPO"), will be offered in addition to already-existing national patents. It will be effective across the EU (except Spain and Italy) and enforceable with a single court ruling.

If ratified by at least thirteen states including France, Germany, and the United Kingdom, a Unified Patent Court ("UPC") will exercise exclusive jurisdiction over unitary patents. The UPC Agreement will come to vote in February of next year. (Notably, the Court of Justice of the EU ruled last March that a proposed unified patents court would not be compatible with EU treaties.) The unitary patent is set to take effect beginning in 2014 or when the UPC is ratified, whichever is earlier.

European Commissioner Michel Barnier declared the "long-awaited agreement" a "decisive contribution to the implementation of the economic and growth agenda." Barnier let the numbers speak for themselves: "In the United States, in 2011, 224 000 patents were granted, in China 172 000 while here in Europe only 62 000 European patents were delivered. One of the reasons for this difference is without a doubt the prohibitive cost and the complexity of obtaining patent protection throughout the single market."

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December 13, 2012

Teratogenic Drug REMS Discussed by FDA Advisory Committee

Thumbnail image for Thumbnail image for Thumbnail image for FDA logo.jpgOn December 12, FDA held a meeting of its Drug Safety and Risk Management ("DSaRM") Advisory Committee regarding development of a framework for addressing what risk evaluation and mitigation strategies ("REMS") are appropriate for teratogenic drugs. Teratogenic drugs are drugs that may cause birth defects for developing fetuses. The Food and Drug Administration Amendments Act ("FDAAA") requires FDA to bring to the DSaRM Advisory Committee for review at least one drug with Elements to Assure Safe Use ("ETASU"), and this was the topic chosen for 2012.

According to the opening remarks, FDA has recognized that over the years, its approach regarding the development of risk management programs for teratogenic drugs "appears to be inconsistent." The DSaRM Advisory Committee began with FDA presentations, continued with stakeholder presentations from industry, prescribers, patients, and then ended with the full committee's discussion of the questions to address:

FDA's proposed framework would take as intrinsic factors: (1) scientific evidence of teratogenicity (biological plausibility, non-clinical data, and human data) and (2) drug-product related factors (characteristic of the drug product, efficacy, and safety profile). The proposed extrinsic factors to consider in the framework are (1) drug product-related factors (actual drug use), (2) clinical-use related factors (characteristics of medical condition, patient population profile, and context of care), (3) regulatory factors (regulatory precedent, previous REMS experience, availability of new REMS tools), and (4) anticipated consequences of REMS.

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