Side Effects - Pharmaceutical Executive

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Side Effects
From research to regulation, drug safety is setting the agenda.


Pharmaceutical Executive


Manufacturers stress that any comparative drug analysis should focus more on effectiveness than on costs. In addition, it should include drugs among a full range of treatment options and recognize that patients respond differently to various treatments and products. Industry has long opposed any move by FDA to require clinical studies of new versus existing drugs in order to bring a new drug to market, as noted in a PhRMA (Pharmaceutical Research and Manufacturers of America) white paper on government-supported outcomes research issued a year ago in anticipation of increased involvement in this area by AHRQ and NIH. A main concern is that comparative studies could block some less effective products from coming to market, even when those drugs offer benefits for certain patients.

Meanwhile, private insurers and payers are supporting more comparative studies, as seen in the growth of the Drug Effectiveness Review Project operated by Oregon's Center for Evidence-based Policy Support. The project is providing 12 states and other organizations with head-to-head comparisons of drugs that treat common conditions such as diabetes, migraine, and elevated cholesterol. The objective is to help health plans select the most effective, cost-effective drugs for formularies, but in today's climate, analysts are paying close attention to safety as well.

Fixing FDA The safety issue is contributing to the clamor to revamp FDA drug regulation. Many old proposals are back on the table after languishing due to a lack of funding. Now Congress may be more willing to ante up the money to expand post-approval monitoring and other initiatives. Look for proposals to:

Strengthen FDA authority to limit product distribution, curb marketing, and enforce safety requirements as alternatives to pulling a risky drug off the market completely. The aim is to give FDA more clout to compel companies to expand label warnings and to revise misleading advertising.

Establish an independent drug safety office. A major debate is expected over proposals to separate the review of safety and efficacy data and to give safety officers veto power over risky new drug applications. Manufacturers and many FDA officials believe it is important to consider safety and efficacy data together to fully evaluate risks and benefits, and FDA is proposing internal changes designed to avoid a major reorganization.

Switch to a "conditional approval" system with a regular schedule to reassess safety and efficacy data in order for a drug to remain on the market.

Expand post-marketing study requirements. All parties acknowledge that many drug effects emerge only after many thousands, even millions, of patients have used a medicine for many months. Thus, there is support for giving FDA more authority to compel manufacturers to conduct post-approval studies.

Require clinical trial registration and study disclosure. Manufacturers are expanding data posting activities voluntarily, but some members of Congress believe that mandated disclosure is needed to ensure that all important safety information reaches prescribers and patients. (For more information, see "See-Through Research".)

Improve FDA's adverse event reporting system to capture and analyze adverse drug event reports more quickly and more effectively. FDA needs additional resources to conduct more prospective safety analyses and to utilize health system databases that collect information on a broad range of drug effects. The new Medicare drug benefit could provide HHS with a gold mine of drug prescribing and utilization data on a fairly vulnerable patient population, which may enhance FDA post-marketing capabilities considerably.

Curb DTC advertising and other marketing activities, particularly for new products and those that raise safety concerns. Critics claim heavy advertising and the resulting inappropriate prescribing of Vioxx and Celebrex turned drugs designed for fairly targeted patient populations into blockbusters, creating serious health problems and boosting healthcare spending.

Jill Wechsler is Pharmaceutical Executive's Washington correspondent.


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