Attacks on FDA Escalate - Pharmaceutical Technology

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Attacks on FDA Escalate
Regulators face demands to improve postmarket surveillance and meet review deadlines.


Pharmaceutical Technology


Another important assignment for OSE is to oversee the new Risk Evaluation and Mitigation Strategies (REMS) program. In March, FDA published a list of 25 approved drugs that already have a restricted distribution system to ensure the products are used safely. Manufacturers of drugs on the list must file new REMS proposals with FDA by September 21, 2008. Listed drugs include innovator and generic versions of clozapine for schizophrenia, the acne treatment isotretinoin, natalizumab, thalidomide, mifepristone, alosetron, and fentanyl citrate.

The announcement also clarifies that FDA can require REMS for new drugs that warrant similar controls on dispensing and patient use. The initial REMS list does not include products that carry MedGuides to support appropriate product use, but a drug in that category might trigger a REMS in the future. FDA plans to issue guidance on the content and format of a REMS to clarify the key elements of a plan for manufacturers who develop new drugs that raise patient-safety concerns.

Drug-safety experts also will take part in FDA's expanded efforts to publicize information about drug-safety signals as they emerge. The same week that FDA published its REMS policy, it also issued several Early Communications about emerging safety issues. One communication involved new signals of heart attack risks involving two leading AIDS therapies, GlaxoSmithKline's (London) "Ziagen" (abacavir) and Bristol-Myers Squibb's (New York) "Videx" (didanosine). The agency also said it would conduct a safety review of Johnson & Johnson's (New Brunswick, NJ) "Regranex" skin gel for diabetics (becaplermin) to assess links to cancer and death. And FDA is investigating a possible connection between suicidality and Merck and Co.'s (Whitehouse Station, NJ) popular asthma treatment "Singulair" (montelukast).

These notices aim to provide information on possible medication problems so that medical professionals can alert patients appropriately. The danger is that these warnings often trigger overreactions that lead to noncompliance. Equally disturbing is the prospect that a proliferation of FDA safety warnings may prompt patients and providers to ignore the alerts. FDA has issued more public-health advisories in recent months than in most preceding years. The agency's new Risk Communication Advisory Committee is working with agency staffers to improve methods for communicating risks and benefits regarding drugs, medical devices, and foods so that the public will respond appropriately.

Recommended funding

Fortunately, the growing consensus is that FDA needs a major infusion of cash to regain its stature as an effective, science-based regulatory agency. Senate Health, Education, Labor, and Pensions Committee Chairman Edward Kennedy (D-MA) added an amendment to the Senate budget resolution for 2009 that supports an extra $71 million for FDA. The extra money could bring FDA's total budget to $2.2 billion if adopted by Congress in the next few months.

That funding level fits recommendations from agency advocates to double the FDA budget over the next five years. Advocates seek a budget of nearly $4 billion by 2013. This goal has support from members of the subcommittee to FDA's Science Board and other groups. FDA needs a "substantial increase in resources if it is to protect us as the public expects and Congress demands," wrote Subcommittee Chair Gail Cassell of Eli Lilly (Indianapolis, IN) in response to requests from Congress. Democratic leaders on Capitol Hill praised the group's funding proposal. They also pointed to FDA's current tight budget as a symptom of how the Bush administration has "shortchanged" the agency. The Government Accountability Office has agreed to provide Congress with a report about FDA's resource needs for "proper operation." This report should further highlight the agency's funding challenges.

In his last months as FDA commissioner, von Eschenbach has become more open about FDA's budgetary problem. In a speech at the National Press Club in February, he acknowledged that FDA's resources "have not kept pace" with its growing responsibilities. In a similar address at the March FDLI meeting, von Eschenbach described FDA as a "patient in peril." He said the agency's expanding responsibilities are made more complex by globalization, bioterrorism, just-in-time delivery demands, and a continuing need for crisis control. Increased FDA reliance on user fees limits the agency's flexibility, von Eschenbach noted. He urged "full backing" for the Reagan–Udall Foundation. "FDA needs to be stronger, bigger, and better," he said, if it is to continue to be "the world's gold standard as a regulatory agency."

Jill Wechsler is Pharmaceutical Technology's Washington editor, 7715 Rocton Ave., Chevy Chase, MD 20815, tel. 301.656.4634,


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