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Volume 24, Issue 2
FDA prepares for top-level changes while promoting transparency and product safety
Late last year, Congress approved a sweeping food safety legislation that provides the US Food and Drug Administration with more authority to recall and monitor food products, boosts its inspection force, and strengthens its capacity to halt unsafe imports. But that may be the last time for a while before 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, the legislators are contemplating severe federal budget cuts and more aggressive oversight of the administration's healthcare policies and regulatory programs. The FDA is a ready target as agency critics move to examine an apparent slow-down in new drug approvals and the agency's difficulties in keeping violative products off the market. It's not clear whether Congress even will provide the $1.4 billion over five years, needed to hire about 2,000 additional FDA inspectors to expand food oversight.
House Democrats continue to support a similar drug safety bill that would give the FDA additional enforcement tools over drugs and biologics, including mandatory recall authority, stiffer civil and criminal penalties, and authority to subpoena records related to drug violations. As with food, there would be a big increase in foreign and domestic inspections and heightened controls on imports and stronger plant registration requirements. But there's not likely to be any action on the measure before 2012, when Congress is scheduled to renew the prescription drug user fee program.
Instead, new Republican committee chairmen are preparing for extensive oversight hearings on administration health reform legislation and regulatory stances. The Chairman of the House Committee on Oversight and Government Reform, Darrell Issa (R-CA), considers FDA a "broken bureaucracy" and has included the agency on his priority investigation list. Issa was highly critical of FDA officials and pharmaceutical executives at hearings before his committee last year on delays in drug recalls by Johnson & Johnson's McNeil Consumer Products unit. Now as panel chairman, Issa plans to hold FDA officials accountable for such regulatory lapses. In December, Issa sent FDA Commissioner Margaret Hamburg a letter questioning FDA's oversight of a contract manufacturer for J&J, and of contract drug manufacturing practices in general. The new chairman also has his eye on the FDA's expanded authority over food production and its growing involvement in tobacco marketing. And FDA's Office of Criminal Investigations is expected to draw scrutiny following criticism of its operations last year by Congress's Government Accountability Office.
Similarly, House Energy and Commerce Committee Chairman Fred Upton (R-MI) is preparing to challenge specific health reform policies, along with "job-killing regulations" that block technological innovation. FDA programs and policies are fodder for the E&C Health subcommittee, which is headed by Reps. Joe Pitts (R-PA) and Mike Burgess (R-TX). In addition, the oversight and investigations subcommittee, under Chair Cliff Stearns (R-FL), may continue to probe drug manufacturing problems, such as FDA's handling of heparin contamination and its failure to adequately monitor foreign drug production.
At hearings last year on J&J's manufacturing problems, the FDA was represented by Principal Deputy Commissioner Joshua Sharfstein, who won plaudits for his command of the issues. 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 in Baltimore. In moving to the state agency, Sharfstein will manage a $7 billion budget and will be involved with implementing the many health reform programs and policies that require state involvement, including an expansion in Medicaid and formation of new health insurance exchanges.
At the FDA, Sharfstein helped engineer a get-tough compliance policy designed to curb perceptions that the agency is too cozy with industry. The stronger enforcement stance has produced more warning letters that cite manufacturing and marketing violations and more criminal investigations. Sharfstein also was involved in strengthening FDA's medical device approval process, which is still ongoing, and he advocated establishing tight curbs on using more risky medicines, such as the 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 of deputy commissioners, chiefs of staff, and special assistants, and Hamburg may move away from the one-deputy arrangement. John Taylor, counselor to the commissioner, is filling Sharfstein's shoes while Hamburg weighs her options, and he is likely to assume a more visible role at the agency.
Taylor has had a long career at the 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 the Biotechnology Industry Organization. Taylor returned to the FDA in 2009 to be Hamburg's top legal advisor, and the commissioner might very well like to have a seasoned enforcement official represent the FDA before contentious Congressional committees.
One of Sharfstein's last activities at FDA was to unveil the third phase of the agency's transparency initiative, which he headed as chair of the agency's Transparency Task Force. Launched in June 2009, the program has established an FDA Basics web page with broad information on agency operations and policies, plus an FDA-TRACK program that measures the performances and accomplishments of agency offices. This latest transparency segment aims to provide manufacturers with useful information on relevant agency policies and procedures. The FDA will post more information on key staffers and meeting presentations; will provide a system to answer sponsor questions quickly; and will clarify agency review processes and procedures for developing new guidances and regulations. The agency also seeks comments on a few more difficult draft proposals, such as whether to set specific timelines for guidance development and how to handle requests from manufacturers to appeal agency decisions.
Of particular interest are two industry proposals that the FDA is rejecting. There will be no binding advisory opinions in response to specific requests from sponsors for clearer decisions on proposed promotional and scientific exchange practices. The FDA says that it will continue to provide its view on whether promotional pieces for drugs and biologics meet regulatory standards before dissemination, but retains the right to change its opinion later on. The FDA also won't commit to notifying companies in advance of publicly disclosing information about the safety of a regulated product. The Center for Drug Evaluation and Research aims to notify sponsors at least 24 hours in advance of posting emerging drug safety information, but says it may not always be able to do so.
Sharfstein, moreover, is leaving the FDA without resolving the most contentious issues under review by the Transparency Task Force. A May (2010) report on phase two of the initiative sought comments on proposals to make public a broad range of confidential manufacturer information, such as when a company files an investigational application and whether that application is put on hold, withdrawn, or terminated (see BioPharm International, Regulatory Beat, July 2010). The FDA also is considering if it should disclose when a firm submits a market application for a new drug, biologic, generic drug, or medical device, and if such applications are withdrawn or abandoned. Most controversial is whether the FDA should make public refuse-to-file or complete response letters, and if the agency should disclose more information from adverse event reports, import evaluations, plant inspections, and product recalls.
Those issues raise "very interesting legal issues" and additional resource requirements, Sharfstein explained at his last FDA media briefing. Agency teams are assessing dozens of comments on these proposals, but resolution is not expected anytime soon.
Jill Wechsler is BioPharm International's Washington editor, Chevy Chase, MD, 301.656.4634, firstname.lastname@example.org.