The report made these recommendations, most of which would require Congressional authorization:
¶ Drugs should only be approved for five-year periods so that the F.D.A. can thoroughly review post-approval safety questions.
¶ Newly-approved drugs should display a black triangle on their labels to warn consumers that their safety is more uncertain than that of older drugs.
¶ Drug advertisements should be banned during this initial period.
¶ The F.D.A. should be given the authority to issue fines, injunctions and withdrawals when drug makers fail — as they often do — to complete required safety studies.
¶ The F.D.A. commissioner should be appointed to a six-year term.
“The new report validates what the watchdog community has been saying for the last two years,” said Senator Charles E. Grassley, Republican of Iowa, who as chair of the Senate Finance Committee has overseen investigations into F.D.A. drug safety problems. “Problems are systemic, and solutions must reflect a new mindset by the agency leadership.”
Subject: MSNBC-Report slams
Charles Grassley, Republican senator and bill sponsor, has consistently called FDA’s drug safety system “too cosy” with drugmakers.
Mr Grassley said yesterday: “This report should be a watershed moment for FDA reform. …Vioxx was like a dead canary in a coal mine, a warning that worse may yet come.”
http://msnbc.msn.com/id/14957815/
Report slams US
By
Updated: 2 hours, 13 minutes ago
The
The Institute of Medicine (IOM) report echoed the harshest critics of the Food and Drug Administration’s drug safety regime. The scathing conclusions found “a lack of clear regulatory authority, chronic underfunding, organisational problems and scarcity of post-approval data about drugs’ risks” in the FDA safety regulation.
The IOM report recommended a number of remedies, which ranged from direct FDA changes to Congressional intervention for funding and legal changes. Its recommendations included limits on advertising for new drugs, increased power for FDA’s drug safety division, more funding, and clearer legal authority and enforcement tools.
Although it is unclear how many of the recommendations could be implemented, the report’s findings will add to pressure on the pharmaceuticals industry. Additional attention to drug risks after approval could affect acceleration of sales, and drugmakers have pushed resources to speed approval of new drugs.
Sheila Burke, chair of report committee populated by respected
The IOM report also serves as another milestone highlighting how the controversy over Vioxx, a painkiller withdrawn by
The FDA commissioned the IOM report after Merck suddenly withdrew Vioxx from the market two years ago. A company study found that Vioxx increased the risk of heart attack and stroke.
Merck had vigorously defended its safety against critics warning of potential heart risks, while also marketing Vioxx to a wide population. Its sales peaked at $2.5bn annually.
Despite a large amount of continuing litigation, the Vioxx controversy reached its crescendo in November 2004 at a Senate hearing on FDA safety efforts.
In his testimony that day, David Graham, a long-time FDA safety scientist, said the
The IOM report and its recommendations are broadly inline with such criticism levied against the FDA.
It cited “problems within the FDA that hinder its post-approval drug safety activities.” It recommended making the drug safety office equivalent in stature to the office of new drugs.
Other recommendations included: giving FDA more power to enforce matters on drugmakers, including fines and injunctions; more money and fewer restrictions on how to spend it; the establishment of a unit to gather and analyse safety and benefit data on drugs; and review of a drug’s risks and benefits formally every five years – a practice similar to European regulators.
It also called for drug labels to clearly denote a product as a “new drug” for two years and a ban on advertising in that period.
The report also broadly echoed some legislation proposed, seeking to restructure the FDA, and to require public disclosure of drug trial data. Charles Grassley, Republican senator and bill sponsor, has consistently called FDA’s drug safety system “too cosy” with drugmakers.
Mr Grassley said yesterday: “This report should be a watershed moment for FDA reform. …Vioxx was like a dead canary in a coal mine, a warning that worse may yet come.”
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