Washington Editor

More than 100 years after the creation of the FDA, the agency said it now will apply the same standards it uses in its premarket drug reviews to manage its post-marketing safety process.

A new initiative, revealed Wednesday by Chief Medical Officer Janet Woodcock during testimony before a House Appropriations subcommittee, is intended to strengthen and modernize the FDA's internal policies and processes for managing the safety of drugs on the U.S. market.

Woodcock also outlined details of the plan in an internal agency email, which was later distributed to some news media, including BioWorld Today.

The new plan comes on the heels of fresh criticism about the FDA's ability to protect Americans from unsafe drugs after the agency revealed earlier this month that it had failed to inspect a Chinese plant where the active pharmaceutical ingredient for Baxter International Inc.'s blood-thinning agent heparin is made. (See BioWorld Today, Feb. 25, 2008.)

Regulators alerted the public Feb. 11 that four people died and hundreds of others became ill after having severe allergic-type reactions to heparin.

Rep. Bart Stupak (D-Mich.), chairman of the House Energy and Commerce Subcommittee on Oversight and Investigations, has called for FDA Commissioner Andrew von Eschenbach to step down in the wake of the heparin safety failure. (See BioWorld Today, Feb. 19, 2008.)

Under the FDA's new two-part program, called Safety First - Safe Use, the agency is expanding the role of its Office of Surveillance and Epidemiology (OSE) in resolving drug-related safety issues.

The agency also is giving OSE the lead regulatory responsibility for areas related to observational epidemiologic studies and medication-error prevention, including review of proprietary drug names and container packaging and labeling.

The FDA, Woodcock said, plans to initiate and maintain a collaborative, multidisciplinary, team-based approach in reviewing drug safety. In addition, she said, the agency will ensure that post-approval safety issues are given the same focus and attention that the FDA's drug development and premarket processes receive.

Woodcock said that the FDA will align its policies and processes to ensure that the most appropriate and best-qualified experts lead or have an equal voice in regulatory decisions.

Lawmakers and patient advocacy groups have criticized the FDA for allowing medical reviewers in its Office of New Drugs, the division that approves drugs, to override the concerns raised by OSE safety officers about certain marketed drugs, like Merck & Co.'s Vioxx.

Sen. Charles Grassley (R-Iowa) has led an effort to give OSE reviewers an equal voice at the agency after some post-market safety reviewers had complained that they were bullied by top FDA officials after raising concerns about certain marketed medications.

The Government Accountability Office (GAO) - the investigative arm of Congress - in an April 2006 report described the dysfunction between the FDA's drug approval and post-marketing safety offices.

The GAO noted that a dispute resolution program launched by the FDA in November 2004, which was supposed to ensure that the opinions of the safety reviewers are included in the regulatory process, had never been used.

While that adjudication process has remained a virgin, there have been several public complaints by FDA reviewers on topics like the controversial approval of Sanofi-Aventis Group's antibacterial drug Ketek (telithromycin) and general drug safety review procedures, the FDA's own ombudsman noted last year in a report.

The newly unveiled plan is not a new effort. Within months of the September 2004 Vioxx debacle, the FDA said it would launch a new post-marketing drug safety initiative.

The agency installed a new leader in its Office of Drug Safety after the office had been led for several years by acting chiefs and renamed it to the Office of Surveillance and Epidemiology.

The FDA also pledged under that earlier initiative to give its post-approval activities more attention and to make that process more transparent to the public by quickly making information on emerging safety issues available.

However, some of the programs under that initiative have gone by the wayside or have had little impact.

But Woodcock said in her email to agency staffers that the FDA now will "ensure that significant post-market safety issues are our highest priority." The FDA's Center for Drug Evaluation and Research will implement new organizational changes, she said, that will include establishing a new deputy director for safety and a safety regulatory project manager as full-time positions in each division in the new drugs office.

OSE will again be restructured, Woodcock said, so that the office can implement its new authorities granted under the Food and Drug Administration Amendments Act of 2007, signed into law Sept. 27, and under the FDA's new safety plan.

The agency, she noted, also now has the funds to build an advanced computer infrastructure to support its quantitative scientists and medical reviewers in the management and analysis of large datasets.

The FDA hopes to have the initial parts of that system in place this year, Woodcock added.

Under the "Safe Use" part of the new initiative, she said, the FDA plans to develop a "cutting-edge" pharmacovigilance system for evaluating drug performance using electronic health data.

That project, Woodcock said, is part of the agency's so-called Sentinel Network, a collaborative program announced last year between government agencies and the private sector to create a nationwide electronic medical product safety network.

The goal of the Sentinel Network, she explained, is to "devise effective, efficient steps to make sure drugs are used as appropriately as possible, in ways that minimize medical errors and manage risks aggressively."

While implementing the new initiative will be a "daunting" task, Woodcock said, the new program ultimately will be a "highly rewarding objective that will extend how we protect the public health."

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