Recent drug warnings may spur major overhaul of FDA safety procedures

Celebrex: Lawyer: Monheit Law: Side Effects: Heart Attack: Drug Warnings

"Each one of these drugs has affected another large group of Americans and, collectively, the spotlight is now shining on the FDA -- more than any other federal agency -- as one in need of reform," said US Representative Edward J. Markey, Democrat of Malden. "I think Congress will be forced to act in the same way that Enron and MCI Worldcom forced an overhaul of the accounting industry in America."

On Thursday, the FDA issued a public health advisory cautioning doctors to restrict Bextra and Celebrex prescriptions to fewer patients, including those at high risk for gastrointestinal bleeding. From January through October this year, doctors wrote 30.7 million prescriptions for those drugs, according to IMS Health, a pharmaceutical information company. The agency did not change either drug's label or remove either drug from the market.

And US Senator Charles Grassley, an Iowa Republican, will introduce legislation to create an office of drug safety independent of the FDA. Markey is eyeing ways to speed the slow pace of safety studies that drug companies promise in exchange for swift FDA approval.

US Senator Edward M. Kennedy, a Democrat working with Republican US Senator Michael B. Enzi of Wyoming, is contemplating widespread FDA reform to bolster the safety of drugs once they're used by millions of Americans. The legislation, still under discussion, would increase the FDA's budget to conduct stepped-up drug safety surveillance.

Epidemiologists would scour massive databases -- such as health records kept for 8.2 million members of Kaiser Permanente, the nation's largest HMO -- to track side effects as drugs are used widely. When the epidemiologists spot a worrisome trend, as they did with Vioxx, targeted studies would look to find the drug's role in causing that side effect.

In addition, Kennedy is keen to add the force of law, so the FDA can require postmarketing safety studies that companies promise, but few complete. Full Story

Ask Monheit Law, "Do I have a Celebrex Case?"

For more information, contact:
Michael Monheit, Esquire, Monheit Law, PC