Drug makers face tightened regulations by FDA and less clout at medical meetings

News outlets report on the pharmaceutical industry and a new requirement by the Food and Drug Administration.

The Washington Post: "The Food and Drug Administration this week began posting online the results of safety evaluations of recently approved drugs and vaccines. The action follows a law enacted in 2007 that requires the agency to provide more safety information to consumers and health professionals. The evaluations must be conducted 18 months after a new drug comes on the market. Rare and sometimes serious side effects are often discovered only when a drug is used by a much larger and more varied group of patients than exposed to it in clinical trials leading to its approval… FDA put up synopses of 26 such reviews Tuesday at http://www.fda.gov" (Brown, 6/17).

The [Milwaukee] Journal Sentinel: Meanwhile, "[p]harmaceutical industry employees will not be allowed to make medical education presentations later this year at the one of the largest medical meetings in the world, the American Heart Association's annual Scientific Sessions. ... The development, which has fired up the medical community, came up last week at a National Institutes of Health meeting in Bethesda, Md. There it was learned that the heart association would not be allowed to let drug industry employees make educational presentations for doctors at its upcoming annual meeting," because of a "relatively new interpretation on a policy of the Accreditation Council for Continuing Medical Education, the national body that accredits medical education courses."

At a Senate hearing last year, Lewis Morris, chief counsel for the Office of Inspector General in the Department of Health and Human Services, "noted a study showing that every dollar spent by a drug company on doctor education activities generated $3.56 in increased revenue. Critics say doctor education had become a vehicle for aggressive promotion of drugs and medical devices" (Fauber, 6/16).

Reuters, on another change in the drug industry: "Across the western world, Big Pharma is cutting back on the number of scientists it employs in its labs and the money it spends on research and development. The hunt for new drugs continues, but the men and women in white coats -- traditionally viewed as the lifeblood of the industry -- are not as untouchable as they once were. … One factor forcing Big Pharma to rethink its business model is the huge number of patents that are set to expire over the next five years," which includes "Pfizer's $12 billion-a-year cholesterol medicine Lipitor and AstraZeneca's $5 billion heartburn pill Nexium. ... Add in tougher regulatory hurdles and a brutal squeeze on healthcare budgets as cash-strapped governments push austerity programs and it's little wonder that drug companies are cutting back and shifting focus" (Hirschler and Kelland, 6/16).

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This article was reprinted from khn.org with permission from the Henry J. Kaiser Family Foundation. Kaiser Health News, an editorially independent news service, is a program of the Kaiser Family Foundation, a nonpartisan health care policy research organization unaffiliated with Kaiser Permanente.