Challenges, Changes, Commitments

One of the last acts of Congress in 2010 was to approve sweeping food safety legislation. The new law provides FDA with more authority to recall and monitor food products, boosts its inspection force, and strengthens its capacity to halt unsafe imports.

Jill Wechsler

But this may be the last time for a while that the legislators bolster FDA's oversight capabilities or authorize added resources. With Republicans taking over the House last month and increasing their clout in the Senate, Congressional leaders are looking to cut federal spending and to aggressively examine administration health policies and regulatory programs. FDA is a clear target as agency critics zero in on an apparent slowdown in new drug approvals and the agency's difficulties in keeping violative products off the market.

Similar legislation to bolster drug safety, moreover, is not likely to move forward in the near future. House Democrats have proposed a bill that strengthens FDA enforcement tools for drugs and biologics, including mandatory recall authority, stiffer civil and criminal penalties, and authority to subpoena records related to drug violations. But there's not likely to be any action on the measure before 2012, when Congress will consider new FDA policies to add on to must-pass legislation renewing prescription drug user fees.

Probing FDA

Meanwhile, new Republican committee chairmen in the House are preparing for extensive oversight hearings on health reform and industry regulation. The head of the House Committee on Oversight and Government Reform, Darrell Issa (R-Calif.), has called FDA a "broken bureaucracy" and put the agency on his priority investigation list. Issa was highly critical of FDA officials and pharma executives at hearings before this committee last year on delays in drug recalls by Johnson & Johnson's McNeil unit. Now as panel chairman, he plans to hold FDA officials accountable for such regulatory lapses.

Similarly, House Energy and Commerce Committee (E&C) chairman Fred Upton (R-Mich.) is preparing to scrutinize the administration's health reform legislation, along with "job-killing regulations" that block technological innovation, and wasteful programs that warrant budget cuts. Upton will be supported by Reps. Joe Pitts (R-Pa.) and Mike Burgess (R-Texas), who head the panel's Health subcommittee, as well as the E&C subcommittee on oversight and investigations, now chaired by Rep. Cliff Stearns of Florida.

Legislators from both sides of the aisle also are paying close attention to FDA's progress in creating an approval pathway for biosimilars and in interpreting the controversial 12 year data exclusivity provision. A flurry of letters to FDA commissioner Margaret Hamburg from key members of the House E&C Committee and the Senate Health Committee point out that the law's provision on data exclusivity—not to be confused with market exclusivity—does not prevent a sponsor from obtaining another 12 years of exclusivity for a "next-generation" version of a reference product, provided it has been sufficiently changed or improved to gain FDA approval as a new drug. Generics makers object that this will permit patent "evergreening" based on minor tweaks in therapies, but innovators maintain that only important product changes will lead to new—not additional—exclusivity.

Changes at FDA

At last year's House hearings on J&J's manufacturing problems, FDA was represented by principal deputy commissioner Joshua Sharfstein, who won plaudits for his command of the issues and forceful responses to questions. Now someone else at FDA will have to fill the hot seat at Congressional hearings, following Sharfstein's surprise departure from the agency last month.

Sharfstein was lured away by an offer to head Maryland's health department, a move that capitalizes on his public health roots as Baltimore's health commissioner. In shifting to the state agency, Sharfstein will manage a $7 billion budget and will be involved with implementing the many health reform policies, such as Medicaid expansion and formation of new health insurance exchanges.

At FDA, Sharfstein helped engineer a get-tough compliance policy designed to curb perceptions that FDA was too cozy with industry. The stronger enforcement stance has produced more warning letters citing marketing and manufacturing violations, along with more criminal investigations of industry. Sharfstein also was involved in reassessing FDA's medical device approval process, a high-profile exercise that remains ongoing, and he was a strong advocate for drug safety and curbs on the use of more risky medicines, such as GlaxoSmithKline's diabetes drug Avandia.

Hamburg is using Sharfstein's departure as an opportunity to re-examine the agency's top management structure. Previous commissioners have tried various organizational models, with various deputy commissioners and chiefs of staff, and Hamburg may move away from the one-deputy arrangement.

Counselor to the commissioner John Taylor is filling Sharfstein's shoes while Hamburg weighs her options, and he is likely to assume a more visible role at the agency in the future. Taylor has had a long career at FDA in legal, enforcement, and regulatory affairs positions under several FDA commissioners during both Democratic and Republican administrations. He rose to be associate commissioner for regulatory affairs from 2002 to 2005 and then served brief stints at Abbott Laboratories and with the Biotechnology Industry Organization. Taylor returned to FDA in 2009 to be Hamburg's top legal advisor, and the commissioner might very well prefer to have a seasoned enforcement official to respond to Congressional probes of regulatory and safety issues.

More Transparency

One of Sharfstein's last officials acts at FDA was to unveil the third phase of the agency's transparency initiative, a program he headed as chair of its Transparency Task Force. Launched in June 2009, the initiative has created an "FDA Basics" Web page, which posts broad information on agency operations. Another innovation is FDA-TRACK, which provides measures of the performance and accomplishments of multiple agency offices and operations.

The latest segment of the project aims to provide regulated companies with helpful material on FDA policies and procedures. FDA will post more information on key staffers and meeting presentations and will provide a system to answer industry questions quickly. To improve the drug application review process, FDA will clarify standard procedures for staff meetings with sponsors about applications, the types of notifications provided to industry, such as those for mid-cycle review meetings, and how it informs companies whether the review of an application is on track to meet a target action date. FDA plans to better explain its process for developing new guidances and regulations, but is still reviewing the more complex issue of whether to set specific timelines for guidance development, or how it should handle sponsor requests to appeal agency decisions.

But these new initiatives fail to resolve the most contentious disclosure proposals, which are still under task force review. A May 2010 report on phase two of the transparency campaign sought comments on proposals to make public a broad range of confidential regulatory information, such as when a manufacturer files an investigational application and whether such an application is put on hold, withdrawn, or terminated (see Pharm Exec, July 2010, page 22). FDA also is considering whether to disclose when a company submits a market application for a new or generic drug or medical device, and if such applications later are withdrawn or abandoned. Most controversial is whether to make public refuse-to-file or complete response letters. And the agency is weighing expanded disclosure of information from adverse event reports, evaluations of imports, plant inspection reports, and product recalls.

Those issues raise "very interesting legal issues" as well as additional resource requirements, Sharfstein explained at his last FDA media briefing. Agency teams are assessing dozens of comments on these proposals. The review is "on track," said Sharfstein, but resolution is not expected anytime soon.

Jill Wechsler is Pharmaceutical Executive's Washington correspondent. She can be reached at jwechsler@advanstar.com