FDA Lawyers Blog

On April 23, FLH Partner Brian J. Malkin will speak at FDLI's Annual Meeting in Washington, D.C. in the Concurrent Breakout Session for the Center for Biologics Evaluation and Research ("CBER"). During the Concurrent Breakout Session, representatives from each FDA center will discuss the three most important developments from last year and their three most important goals in 2013. Following the FDA center representative presentations, food and drug law stakeholders responding to their presentations. This year Diane Maloney, Esq., Associate Director for Policy, CBER, will be presenting for CBER, and Mr. Malkin will be responding as a food and drug law stakeholder. Scott Cunningham, Partner, Covington and Burling, will moderate the session. The Concurrent Breakout Sessions are always a big draw for attendees at FDLI's Annual Conference, and Mr. Malkin hopes to see you there and at the CBER Breakout Session.

In a surprising turn of events, last week FDA's new Office of Generic Drugs ("OGD") Director Gregory P. Geba, M.D., M.P.H., voluntarily stepped down from his post after only about eight months after being announced as the new Director. Rather than hiring from within, FDA hired Geba from Sanofi US, where he had previously most recently served as Deputy Chief Medical Officer. FDA said then, "He [Geba] joins OGD at an opportune time to lead our expanding generic program into a reorganization of both structure and process to improve coordination, communication, and efficiency, as well as enhance the Office's ability to ensure that all generic drugs--which make up nearly 80 percent of prescriptions filled in the United States--are safe, effective, of high quality, and interchangeable with the brand name drug product/reference listed drug." Around this same time, FDA moved OGD to the same organizational level as the Office of New Drugs ("OND"), called a "Super office," signaling that the two offices now had the same reporting structure directly to the Director of the Center for Drug Evaluation and Research ("CDER"), Janet Woodcock, M.D., rather than a sub-office, as had previously been the case.

According to reports of an e-mail that Geba sent to FDA staff on March 13, Geba cited the movement of OGD's chemistry divisions into a new Office of Pharmaceutical Quality as one of the lead reasons for his resignation, as well as the relocation of his family to the Washington area. Geba reportedly wrote: "As I see it, two of the original reasons I came to [OGD] . . . would be challenged by resources needed for application to other extremely important efforts of the chemistry group in moving to [the Office of Pharmaceutical Quality." The e-mail explained that while Geba generally supported the transfer of the chemistry group to the Office of Pharmaceutical Quality. Geba thought, however, that the move could make it difficult for him to achieve his goals to approve generic versions of inhalers, topical creams, and other complex drugs, as well as addressing the importance of pill size, shape, color, and other characteristics to patients.

Written by Brian J. Malkin

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Geba helped FDA with its initial phases for implementing the Generic Drug User Fee Act ("GDUFA"). According to Geba, since GDUFA, OGD decreased the abbreviated new drug application ("ANDA") backlog by nearly 600 applications and approved nearly 200 ANDAs since October 2012.

Written by Brian J. Malkin

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The last day of the Generic Pharmaceutical Association ("GPhA") 2013 Annual Meeting also featured an FDA Keynote Address by FDA Commissioner Margaret A. Hamburg, M.D. For a summary of public sessions from Day Two, please see the previous blog here; a summary of the CEOs Unplugged session may be found here.

Video streaming by Ustream

Following the CEOs Unplugged session on day three, Hamburg delivered her Keynote Address. Hamburg said that GPhA was one of the few organizations that she has chosen to address each year since becoming Commissioner, "because of the dynamic character of this group, your prominent role in the nation's health care system and the importance of the work you do." Celebrating GDUFA and the FDA Safety and Innovation Act ("FDASIA"), Hamburg emphasized that FDA is making "quality one of the highest priorities this year," hoping that GPhA's members do the same. Despite generic drug companies providing 85 percent of all prescriptions filled, some studies have suggested that many physicians still have "negative perceptions about the quality of generic medicines," which Hamburg said was "troublesome - and assuredly not fair."

Hamburg reported "impressive strides in implementing GDUFA," explaining that FDA got the word out of new requirements and fees early, resulting in the collection of almost $125 million in fiscal year 2013 user fees to help brining in staff and other resources to help reduce the backlog of ANDAs above 2,500 applications with median review times at about 31 months. FDA has assembled a list of about 2,000 facilities supplying generic drugs to the U.S. following self-identification procedures.

Today, 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.

Written by Brian J. Malkin

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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.

FDA's various user fee acts ("UFAs") have not reached their implementation date in October 2012, yet FDA has already begun announcing staff changes to help with overseeing the new changes.

On the Commissioner level, Peter Lurie will be replacing David Dorsey as Acting Associate Commissioner for Policy and Planning. In a September 12 staff memorandum, FDA Commissioner Margaret A. Hamburg, M.D. announced the departure. Dorsey is leaving FDA to be a senior director in global regulatory policy and intelligence at Janssen Research & Development LLC in Rockville, Maryland. Hamburg wrote in the staff memorandum:

Throughout his long government tenure, David's colleagues repeatedly have sought him out for his extraordinary depth of knowledge, his vast experience on the Hill and at the agency, his thoughtfulness, and his patience under pressure. . . . David's departure will be a loss to the agency, and we will miss him.

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This changes follows a few earlier FDA staff changes at the Commissioner level and elsewhere last month. First, Associate Commissioner for Regulatory Affairs Dona Carrigan was announced as the new Director of FDA's Europe Office and Senior Advisor for Global Operations, stationed in Brussels, Belgium. Carrigan's new position is designed to help implement the Agency's strategic and risk-based global industry oversight and enforcement. Next, Melinda Plaisier will be Acting Associate Commissioner for Regulatory Affairs effective October 1. Plaisier was previously the Regional Food and Drug Director in the Office of Regulatory Affairs' central region, and before that she was Associate Commissioner for Legislation and Associate Commissioner for International Programs.

by Charles J. Raubicheck

FDA Commissioner Margaret Hamburg has announced Elizabeth ("Liz") Dickinson was appointed as the Chief Counsel of FDA, effective March 12, 2012.

The new Chief Counsel has had a long and distinguished career at FDA since she joined the agency in 1994. She has principally served as legal counsel to FDA's Center for Drug Evaluation and Research, providing advice in such key areas as Hatch-Waxman generic drug approvals, pediatric exclusivity and orphan drugs. She has also worked closely with the Department of Justice representing FDA in many court cases. Liz is well respected by both her colleagues at FDA and outside lawyers representing companies in FDA-regulated industries.

Among the imminent issues that Liz will face at FDA include generic drug user fees, drug shortages, and regulations/guidances for the Agency's implementation of new statutes on food safety and tobacco products.

Liz received her B.A. in Economics from the University of Massachusetts, and her J.D. from Northeastern University. She clerked for Judge William B. Bryant at the U.S. District Court for the District of Columbia.

Mark Raza will continue to serve as the Acting Principal Deputy Chief Counsel.

by Brian Malkin

On January 26, FDA's Acting Chief Counsel, Elizabeth H. Dickinson, Esq., and FDA's Deputy Center Director for Policy, Center for Devices and Radiological Health ("CDRH"), Nancy K. Stade, Esq., spoke at the Annual Meeting of the Food, Drug and Cosmetic Law Section of the New York State Bar Association. Dickinson provided an overview of the year's hot legal issues and Stade offered her views on FDA's efforts for improving its medical review process and plans for the future.

Stade spoke first in a spirited debate between former FDA and current consultant Philip J. Phillips, Esq., President, Phillips Consulting Group, LLC, Professor Ralph F. Hall, Professor of Practice, University of Minnesota Law School, and Partner, Lauren R. Silvis, Esq., Sidley Austin LLP. Section 513 of the Food, Drug, and Cosmetic Act ("FD&C Act") mandates that, prior to marketing, FDA must classify all medical devices into one of three classes depending on the intended use, indications for use, and level of control necessary to ensure the safety and effectiveness of the device. Class I requires the least control, followed by class II, and class III requires the most control. Section 513(i) of the FD&C Act essentially states that if a new device is substantially equivalent to an already-marketed device or "predicate" device, the new device is given the same classification as the device already in the market and may be submitted as a "510(k)" submission, which is based on section 510(k) of the FD&C Act. If the new device is not substantially equivalent to any such device, the new device is placed in class III and requires a premarket approval application ("PMA") under Section 515 of the FD&C Act.

Over the years, the 510(k) process has become the most common and controversial pathway for bringing medical devices to market. FDA's definition of medical device includes products ranging from simple tongue depressors to pacemakers to laser surgical devices. Under the current 510(k) process, device manufacturers must notify FDA of their intent to market a medical device at least 90 days prior to launch. If FDA determines that the device is substantially equivalent to an existing 510(k) cleared device or other device that was on the market when the Medical Device Amendments were enacted in 1976, then it may proceed to market. If not, it must undergo pre-market approval as a premarket approval application ("PMA").

by Brian Malkin

On December 23, FDA launched its newest official blog called "FDA Voice". FDA Voice's first blog entry, authored by FDA Commissioner Margaret A. Hamburg, M.D., explained that the purpose of the blog is for senior FDA leadership and staff to explain topics about the work done at FDA that they think would be of interest to the American public. While FDA Voice is very new, it has already featured three blogs from Hamburg and several from other key FDA leadership, such as the Director of the Center for Devices and Radiological Health, Jeffrey Shuren, M.D., J.D. Some of the first topics have featured FDA explaining FDA's views and responses to criticisms concerning FDA's medical device program, FDA's advisory committee process and recent questions raised about the potential for a conflict of interest, particularly financial interests, as well as FDA's recent user fee proposals sent to Congress, which we reported on yesterday. Other topics appear to be more akin to what you might find elsewhere on FDA's website concerning consumer information, such as how to read a children's medication label.

In addition to the blogs themselves, FDA Voice offers links to news items on FDA's website and FDA's presence in the social media, including Facebook and Twitter. FDA Voice joins other FDA "transparency initiatives" such as its own FDA Transparency Blog.

FDA Lawyers Blog wishes FDA Voice success in its launch and looks forward to its new insight into FDA's thinking and procedures.

by Russell A. Garman, Ph.D.

The world of drugs, medical devices, and food products has changed substantially over the past 30 years, and now, FDA is changing with it. In an e-mail memorandum sent to FDA employees, Commissioner Margaret A. Hamburg, M.D. announced that the FDA is realigning its management structure from a system that has been in place since 1970. Aimed to "more accurately reflect the agency's responsibilities, subject-matter expertise and mandates in an ever more complex world, where products and services do not fit into a single category," the realignment involves the division of the FDA's programs into "directorates" that "reflect the core functions and responsibilities of the [FDA]."

The first directorate will be led by the newly-created Deputy Commissioner for Medical Products and Tobacco, who will "provide high-level coordination and leadership across the Centers for drug, biologics, medical devices, and tobacco products" and "will oversee [the FDA's] Special Medical programs." To fill this position, Commissioner Hamburg has brought in Dr. Steven Spielberg, former Dean of Dartmouth Medical School and currently Director of the Center for Personalized Medicine and Therapeutic Innovation at Children's Mercy Hospital in Kansas City.

The second directorate will be lead by the newly-created Deputy Commissioner for Global Regulatory Operations and Policy, who will oversee the transformation of FDA from "being a regulator of domestic products to one overseeing a worldwide enterprise" to handle the global nature of food and drug production and supply. This position will have a specific mandate to make import safety a top priority. This position will be filled by Deborah Autor, an attorney who now is Director of the Center for Drug Evaluation & Research.

by Laura Fanelli

Last week, it was announced that effective January 7, Joshua M. Sharfstein would be leaving his post as FDA's Deputy Commissioner. Sharfstein's resignation was the result of his accepting a new role as Maryland's top public health official, Secretary of Health and Mental Hygiene, by Maryland's Governor, Martin O'Malley. Sharfstein has commented that his resignation was not because he was looking to leave the Agency. Instead, he stated, "I was committed to the FDA. But opportunities like this don't come along very often. It's a really great job at a really important moment in time, and with terrific leadership in the state," as reported by Lyndsey Layton and John Wagner of The Washington Post.

As a result of Sharfstein's departure, FDA Commissioner Margaret A. Hamburg, M.D. named John Taylor, FDA's legal counselor to Hamburg since 2009, as Acting Deputy Commissioner. Taylor will be acting in the role for 60 days beginning on January 10. Although Taylor does not have a medical degree, he has expansive knowledge of FDA and the product areas it regulates. This knowledge is the result of his long FDA career, as well as prior positions in the biotechnology, pharmaceutical, and medical device fields.

Hamburg also announced several other personnel changes. (The Pink Sheet, Jan. 5, 2011). The memorandum announcing these personnel modifications suggests that restructuring FDA's senior administrative positions and job responsibilities are approaching. Hamburg stated that she will be consulting with senior FDA leaders to evaluate specific functions and positions. "My top priority is advancing FDA's public health mission, and I want to ensure all our resources--from our programs to our key staff positions--are as efficient and well-organized as possible," Hamburg said.

by Justine K. Donahue

On November 1, Gary Buehler, the longtime director of FDA's Office of Generic Drugs (OGD), is joining Teva Pharmaceutical Industries Ltd. as Vice President of Regulatory Strategic Operations.

Notably, as a former senior government employee at FDA, there are certain restrictions Mr. Buehler has to observe in his new position at Teva:

(1) He can never (i) appear before or communicate with FDA about matters in which he personally and substantially participated during his tenure at the Agency; (ii) use trade secret information that FDA obtained from businesses or individuals while he worked there, or (iii) share with industry non-public information he learned by virtue of his FDA employment.

(2) For a period of two years, he may not appear before or communicate with FDA on matters that were pending before OGD during the one-year period prior to his departure.

(3) For a period of one year, he may not appear before or communicate with FDA on any matter.

Nonetheless, these curbs do not prevent Mr. Buehler from providing internal advice to Teva management and Teva employees about current and future matters in which Teva has an interest at FDA. See here. This valuable assistance, coupled his wealth of experience at the Agency, are significant advantages Teva has gained by hiring him.

by Andrew M. Nason

On September 21, the Food and Drug Law Institute ("FDLI") reported that FDA named Karen Midthun, M.D., Director of its Center for Biologics Evaluation and Research ("CBER"). FDA appears to have made the appointment without any formal notice or press release. Dr. Midthun's assistant confirmed to FDA Lawyers Blog that Dr. Midthun was named Director following approximately 18 months as CBER's Acting Director. Previously within FDA, Dr. Midthun served as CBER's Deputy Director and CBER's Director of the Office of Vaccines Research and Review.

Dr. Midthun received her bachelor's degree from the Massachusetts Institute of Technology and her medical degree from the George Washington University School of Medicine. She trained as a resident in internal medicine at Johns Hopkins Hospital and as a fellow in infectious diseases at Johns Hopkins Hospital and the National Institute of Allergy and Infectious Diseases. She currently trains as a fellow at the Infectious Diseases Society of America and acts as a member of the American College of Physicians and the American Society for Virology.

Dr. Midthurn joined FDA in 1993. For more information, see Dr. Midthun's biography.