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Major drug companies fight stronger restrictions on off-label marketing on drugs


WASHINGTON Ten major drug companies have formed a coalition and will submit their arguments to the Food and Drug Administration to push for looser proposed restrictions on off-label marketing, according to published reports.

The 10 companies include Pfizer Inc., Bayer Corp., the U.S. unit of Bayer AG; AstraZenecaPLC; and Johnson & Johnson who will be represented by Daniel Troy a former FDA Chief Counsel and is currently working with APCO Worldwide Inc.

Merck & Co., according to two reports from the Journal of the American Medical Association, was reported to have not effectively marketed the risks of its painkiller, Vioxx, which reportedly served as a risk for heart attack to Alzheimer’s patients. Congressional investigators also have accused Merck and Schering PloughCorp, the makers of Vytorin, a cholesterol drug, of trying to withhold information that questioned the drug’s effectiveness. These two instances are one of many in which Congress is trying to place stronger restrictions on the companies marketing strategies for these drugs.

According to published reports, a poll conducted during an annual conference sponsored by the drug-marketing magazine DTC Perspectives stated that 60 percent of participants felt that Congress might place limits on TV advertising for pharmaceutical companies. Another idea that the drug companies are not in favor of is to place a telephone number in ads, so consumers can call the FDA  to express their problems with a specific drug.

According to published reports, the chairman of the House Committee on Energy and Commerce, Michigan Democrat John Dingell already is taking this issue seriously by calling a hearing on direct-to-consumer advertising. In a statement regarding this issue,  Dingell said, "Drug companies should know that they would be held accountable for inappropriate behavior and inaccurate representations made in their ads." The hearing is expected to take place in a few weeks.

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