FDA Lawyers Blog

On April 23 and 24, 2013, the Food and Drug Law Institute ("FDLI") held its Annual Conference in Washington, D.C. As expected, FDLI's Conference featured the FDA Commissioner, Margaret A. Hamburg, M.D., presentations from leaders from all of FDA's Centers and the Chief Counsel, Elizabeth Dickinson, and leaders from industry, academia, and the legal bar. Unlike previous years, however, there were far fewer FDA attendees due to budget cuts, and FDA seemed more reluctant to use the Conference as a platform for announcing new policy or initiatives.

Hamburg kicked off the Conference with her recognition that FDA's budget was cut, along with other government agencies, noting that it would make times tight but that there are no planned furloughs. Hamburg said that this fiscal year, FDA lost about $209 million-$126 million in budget authority and $83 million in user fees. FDA will continue to collect user fees, but FDA cannot use them this fiscal year due to the sequesteration issue. Hamburg said that the reduced budget would mean reductions in programs but did not specify which ones. Yet, at the same time, Hamburg emphasized that FDA has been busy implementing its new regulatory authorities, including the new Center for Tobacco Products and authorities in the Food and Drug Administration Safety and Innovation Act ("FDASIA").

Hamburg stressed that it has become more and more apparent that its regulated industries need to build quality in their products. She highlighted that quality issues have caused two out of three drug shortages, and FDA has uncovered "shockingly unsafe drugs" at compounding pharmacies. Over the past several months, Hamburg explained, FDA has been inspecting compounding pharmacies and has found unidentified black particles in what were supposed to be sterile injectable products, rust and mold in sterile rooms, and products being processed with bare hands. At the same time, FDA has encountered increased resistance during its inspections, resulting in at least two cases needing administrative warrants. Hamburg said that FDA believes there should be a distinction between traditional and nontraditional compounding--traditional is individualized to patient; nontraditional is sterile product prepared out of state compounded and anticipated without a prescription. For nontraditional compounding, FDA has asked Congress for more clear FDA authority to monitor and examine records in the "patchwork" of compounding rules.

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.

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.

Eric "Rick" Blumberg, an attorney with FDA for over 40 years, passed away unexpectedly yesterday. His noteworthy achievements include winning the Park case, which reaffirmed the strict liability rule in FDA criminal proceedings, and implementing the doctrine of disgorgement in FDA enforcement actions. A graduate of Washington & Lee and Georgetown Law, he will truly be missed by the FDA bar.

With the $85 billion spending cuts now in effect, it is time for FDA and other agencies to adapt. The 2013 impact will be condensed into the next seven months because the federal fiscal year ends on October 1. While few details have been made available, FDA Commissioner Margaret A. Hamburg, M.D. said in an interview on Thursday that she did not anticipate FDA having to furlough workers and emphasized that the majority of the effects would not be felt in the short term. However, Hamburg estimated that the cuts will result in more than 2,000 fewer food safety inspections: "[C]learly we will be able to provide less of the oversight functions and we won't be able to broaden our reach to new facilities either, so inevitably that increases risk." FDA may renew efforts to implement a user fee program for the food industry to offset this hit.

President Barack Obama has vowed to continue to work with Congress to reach a compromise that would replace the cuts with a more balanced budget plan. Meanwhile, the House Appropriations Committee introduced a bill yesterday that would fund the government with $982 billion through the end of the fiscal year, assuming the sequester cuts would remain in effect. While largely focused on the Department of Defense ($518 billion) and military construction and Veterans Affairs ($71.9 billion), the general provisions maintain the funding level of the Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2012. The bill is scheduled to reach the House floor tomorrow.

Absent an agreement in today's Senate votes on dueling legislative proposals to prevent the budget "sequester," automatic wholesale spending cuts will likely take effect tomorrow evening in the form of a 5% hit for all government agencies. This will amount to $85 billion (2.4% of the federal budget) in total. The cuts are a result of a 2011 law mandating that, if Democrats and Republicans should be unable to agree on a plan to reach the goal of $4 trillion in deficit reduction, then over a trillion dollars of arbitrary cuts would start to take effect this year. The draconian nature of the law was an intentional effort to force the parties to reach some other compromise.

A failure to achieve that goal may now have serious consequences, in particular for the healthcare industry. Estimated cuts for this fiscal year include $210 million to FDA, $1.6 billion to the National Institutes of Health ("NIH"), and $11 billion to Medicare. While the so-called "mandatory" programs (Medicaid, the Children's Health Insurance Program, and Social Security) are exempt, the remaining reductions have given the industry more than enough to worry about. According to Bill Hall, spokesman for the Department of Human Health and Services, "It will affect all disease areas, all research areas. Because it is across the board and deep down in every single institute, it would affect virtually everything."

More specifically, hospitals and doctors anticipate a 2% cut in Medicare reimbursement fees and, by some estimates, up to 200,000 job losses; the pharmaceutical industry expects a substantial increase in drug and medical device approval delays from FDA; and research institutes will undoubtedly see the effects of the NIH cuts. Francis Collins, director of NIH called the sequester "sand in the engine" that will force NIH to reject 1,000 promising new research proposals. As a result, he continued, "Medical research in America will be slowed by this, advances that could have happened sooner will happen later or perhaps not at all..." The pharmaceutical industry may also see effects of research program cuts to the extent of NIH-industry collaboration.

On September 19, ten top U.S. and European drugmakers announced that they have formed a new nonprofit organization called TransCelerate BioPharma Inc. ("TransCelerate") to help improve how experimental drugs are tested to get them to patients sooner. The New York Times broke the story, along with the Associated Press and Reuters getting the word out for this organization that has been in the works for about a year.

The ten companies are: (1) Abbott Laboratories Inc., (2) AstraZeneca Plc, (3) Boehringer Ingelheim, (4) Bristol-Myers Squibb Co., (5) Eli Lilly and Co., (6) GlaxoSmithKline Plc, (7) Johnson & Johnson, (8) Pfizer Inc., (9) Roche Holding's AG Genentech, and (10) Sanofi SA. TransCelerate's headquarters will be in Philadelphia, Pennsylvania, which it hopes to open later this year. All of the companies will contribute financial and other resources but for right now scientists and other staff are working from their corporate offices.

FDA's Director for the Center for Drug Evaluation and Research ("CDER"), Janet Woodcock, M.D., supported the move, said in a statement,

We applaud the companies in TransCelerate BioPharma for joining forces to address a series of longstanding challenges in new drug development.... This collaborative approach in the pre-competitive arena ... has the promise to lead to new paradigms and cost savings in drug development, all of which would strengthen the industry and its ability to develop innovative and much-needed therapies for patients.

The interim chief of the effort is Garry Neil, former Corporate Vice President for Science and Technology at Johnson& Johnson. "There's never been anything like this to take on these big challenges," Neil said, who has so far offered no details on how big this project will get other than the initial focus would be five projects to make clinical trials more efficient with a budget in the millions of dollars. "We want to simplify, standardize, and also raise quality. ... We worry about potentially promising drugs which might not get studies unless we can increase the overall efficiency of the system. I think it will make it easier for companies," Neil added.

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.

(The Pink Sheet, September 13, 2012).

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.

FDA Lawyers Blog is pleased to invite you to nominate FDA Lawyers Blog to the American Bar Association's ("ABA's") annual list of the best 100 legal blogs. The short ABA's Blawg 100 Amici Form may be found here.

Nominations are due no later than September 7, 2012.

Here are the criteria to keep in mind when nominating FDA Lawyers Blog or other legal blogs to the list-straight from the ABA's website for Amici:

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The ABA discourages nominations from:

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Thank you for reading FDA Lawyers Blog. We have been running for more than two years strong and plan to keep it that way. We also invite you to send us a comment through the blog if there are topics or things that you think we could do better. For example, in addition to our unique resources on Biosimilars and European Drug Law, what additional resources would be useful for you?

We are constantly trying to improve our blog as well as how it interfaces with you. Last year, we were one of the first blogs to introduce Mobile Applications for iPhones and Android that not only delivered blogs from FDA Lawyers Blog but also key FDA news feeds and a phone-ready HHS directory. A few weeks later, we introduced our custom-designed mobile style sheets for FDA Lawyers Blog to optimize your viewing experience of the Blog on any smartphone or mobile device, whether or not one of the apps were downloaded. This year we continued our trail-blazing trend to incorporate Google+ into our social media platform that already included Facebook, Twitter, and LinkedIn. And we did not stop there. We then customized our Contributors' profiles to flow more like an electronic resume to make them more readable for business professionals. Last week, we revised our "About" section to incorporate additional information about the FDA/Regulatory Group at Frommer Lawrence and Haug LLP.

We look forward to continuing to blog about FDA news and topics that interest you and keep you on top of new developments. Thanks for reading!!!

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 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 Kyle Deighan

Last Thursday, FDA released a report, entitled "FY 2011 Innovative Drug Approvals" touting the number of drugs it approved over the past 12 months. The report boasts, "FDA's performance during the most recent fiscal year . . . demonstrates that the FDA continues to lead the world in rapid, high-quality drug reviews." The report indicates that FDA approved 35 new medicines in the past year, the second-highest number of approvals in a single year in the past decade. Only 2009 saw more approvals, with 37.

FY2011

Margaret A. Hamburg, M.D., FDA Commissioner, stated that "we approved a set of drugs that are truly medically important, and in fact did so in a way that made these drugs available to Americans before other places around the world." According to the report, FDA approved almost 70% (24 of 35) of the new drugs before they were approved in other countries, including the European Union. To help bring about the speedy review process and subsequent increase in approvals, FDA utilized an accelerated review and approval process and streamlined the requirements for clinical trials to allow for smaller, shorter, or fewer studies where possible. However, FDA was careful not to take too much recognition. "We're not taking credit for these innovative medicines, but we are trying to demonstrate that by working closely with industry and the broader biomedical research community, we can produce the kind of innovative medicines the American public needs," Hamburg stated.

The report indicates that many of the new approvals are groundbreaking drugs, including "the first new drug to treat Hodgkin's lymphoma in 30 years and the first new drug to treat lupus in 50 years. The 35 novel drugs are noteworthy for their contributions to the health of Americans and their scientific innovation." The drugs are designed to treat a variety of ailments, including "hepatitis C, late-stage prostate cancer, lupus, drug resistant skin infections, pneumonia and other serious and life-threatening diseases," in addition to various advances in cancer treatment and heart attack, stroke and kidney transplant rejection therapies.

by Brian Malkin

FDA Lawyers Blog is pleased to announce that its style sheets for iPhones and Android smartphones are now complete. These style sheets are In addition to mobile apps for iPhones and Android smartphones that can be downloaded directly from the Apple App Store and the Android Market free of charge. Together, FDA Lawyers Blog's mobile style sheet and iPhone and Android apps provide a new global level of accessibility and usefulness for professionals in the field of FDA law.

As we previously mentioned, the mobile style sheets make FDA Lawyers Blog more readable on your iPhone or Android smartphone. First, the style sheets provide you with an initial pop-up to choose to download the iPhone app, the Android app, or to go directly to the mobile style sheets for the blog ("TAP HERE TO CLOSE"). You should only see this pop-up once unless you clear your browser's cache (cookies and data).

Once you enter FDA Lawyers Blog's mobile style sheets, you are provided with a similar but somewhat different interface than the full version of FDA Lawyers Blog. Recognizing that individuals utilizing FDA Lawyers Blog on the move may want to locate particular blog items quickly, we moved a search bar up to the top (as opposed to a separate "Search" tab in the full blog). The most recent blog appears as it does on the full version of the blog, whereas older blog items are truncated after about a paragraph to make scrolling to blog items easier with "Continue reading" features to permit readers to view the full blog. To make reading the blog items easier, the mobile version focuses on the text in the blog, increasing its font size to permit readability in an upright mode without the need to flip the phone on its side or increase font size on the screen.

Following the most recent blogs are other features found on the full version of the blog. First, there is the contact screen, then subject headings to locate particular blogs by subject, then the "Events" and "Articles" tabs that feature FDA Lawyers Blog contributors on FDA-related topics.

Towards the bottom of the screen is a button "View Full Version" that permits readers to toggle to the full version of FDA Lawyers Blog on an iPhone or Android smartphone. When you want to go back to the mobile version, towards the bottom right-hand corner of the full version is a button "View Mobile Version" that permits readers to toggle to the mobile style sheets once again.

We hope that you enjoy both the mobile style sheets and iPhone or Android smartphone apps. Please continue to watch for additional updates as we listen to your comments about what you need to be more productive with regard to FDA news and updates.

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by Brian Malkin

On October 23, the 25th Annual Meeting and Exposition of the American Association of Pharmaceutical Scientists ("AAPS") kicked off with a Keynote Address from FDA' Director for the Center for Drug Evaluation and Research, Janet Woodcock, M.D., reflecting on the past 25 years of drug regulation and how they may help inform the next 25 years. Woodcock's premise was that the macroenvironment is a driver for the changes she has seen and expects to see in the future.

by Brian Malkin

FDA Lawyers Blog wanted to make you aware that there are important updates for their mobile apps for iPhones and Android smartphones. The apps feature FDA Lawyers Blog, key FDA news feeds, and a phone-ready HHS directory and can be downloaded directly from the Apple App Store and the Android Market free of charge. The iPhone update makes the app compatible with iOS5 and the Android app fixes a minor stability issue.

We previously mentioned that FDA Lawyers Blog was in the process of optimizing its blog to make it more readable on your iPhone or Android smartphone. We are almost done with those changes, but we will let you know when it is complete. We hope that you find the blog more readable on your smartphone whether you choose to use the apps or the native browser on your phone. Please note that if you choose not to select downloading one of the apps for your phone, the app pop-up will not appear again unles you clear the cache in your phone's browser.

Continue to watch for additional upgrades as we listen to your comments about what you need to be more productive with regard to FDA news and updates.

FDA Lawyers Blog is proud to announce that for six years years running, FLH Partner Charles J. Raubicheck as been recognized as an FDA "Super Lawyer" in Thompson Reuter's Super Lawyers publication for the New York Metro area. The process to become a "Super Lawyer" begins with peer nominations, then candidate research, and ends with a review of candidates by their peers within their primary area of practice.