Market Spotlight: Pharma & drug safety

-CNN

12/04/2007 - Drug developers are just beginning to grapple with recent FDA oversight reforms, but already industry and consumer advocates disagree on how well the overhaul will be able to prevent future drug safety scandals.

Signed by President George W. Bush in September, the measures give the Food and Drug Administration more authority over and responsibility for the safety of prescription drugs after they hit the market. While follow-up historically fell under the agency's purvue, practically speaking the FDA focused on monitoring drug development and reviewing treatments for approval.

But safety scares in recent years sparked closer scrutiny of both drugmakers and the FDA, along with big changes.

Despite a rigorous and costly development process prior to FDA approval, a drug's side effects can go unnoticed or be deemed insignificant in small clinical populations. But once a drug hits the general market and is consumed by millions, fatal risks become apparent.

'The public and myself as a patient would like to have a 'one size fits all system' that could identify all types of risks, but the reality is there are some risks that won't be found very easily,' said Gretchen Dieck, Pfizer Inc.'s (NYSE:PFE) head of safety and risk management reports.

Drugmakers and the FDA have been criticized for acting too slowly to add warnings to drug labels or recall medicines in the wake of serious safety findings. Calls for reform go back to diet pill Fen-Phen's removal from the market in 1997, but intensified after Merck & Co. (NYSE:MRK) recalled its Cox-2 inhibitor Vioxx due to research showing it doubled patients' heart-attack risk.

The company agreed last month to settle 60,000 lawsuits over the painkiller for $4.85 billion. British drugmaker GlaxoSmithKline (NYSE:GSK) also in November said it will add safety warnings to diabetes drug Avandia due to concerns it raises cardiac risks.

The bill calls for a broader range of safety-tracking resources, allowing drugmakers and regulators to cull information from hospitals, physician groups and health insurers as well as the Centers for Disease Control. It imagines the creation of a data pool of 25 million patients by 2010 and 100 million patients by 2012 for drugs on the market, though logistics are still under development.

It's still too early to predict possible costs or cost savings, members of the industry say. And, though Pfizer's Dieck and others agree that more information will be beneficial, they are unsure of just how transformative the new setup can be.

Former FDA Commissioner and Centers for Medicare and Medicaid Services administrator Dr. Mark B. McClellan said at a recent health care conference in New York that the system is likely to reduce the time it takes to discover safety issues. But some say it will take more than a database to effect fundamental change in drug safety, and suggest a shakeup at the FDA may be in order.

'It isn't just a matter of funding, it's a matter of decision making,' said Dr. Sydney Wolfe, director of the health research group at consumer and public advocacy organization Public Citizen. 'Ultimately, something structurally has to be done.'