re: Drug companies protected by FDA and patent law raise prices in unison again

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anti-competitive corruption perpetuated by government.

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Over the last few years, exposés and articles on the FDA’s cozy relationship with drug companies have appeared in a WGBH Frontline telecast, the Boston Globe, the Washington Post, and the New York Times. Beginning with the Prescription Drug User Fee Act of 1992, Congress required drug companies to pay up to half a million dollars to the FDA with each new drug application. The money was used to hire more reviewers to get drugs on the market more quickly. By 2003 over half the FDA’s drug reviewers were paid with industry money and approval time for drugs had gone from over two years to less than six months. In fiscal 2006 industry money paid to the FDA was estimated to hit $382 million.

Meanwhile, the culture at the FDA had become industry friendly, which included a reluctance to challenge company claims about drug safety and effectiveness. The number of drug approvals became part of FDA employees’ performance evaluations. FDA reviewers were pressured to approve drugs or soften the language in their reviews or on drug labels. It became common for researchers with ties to the drug industry to serve on FDA advisory panels. In 2005, in the wake of a series of drug-safety scandals and criticism from Congress, the FDA changed course again, issuing a flood of drug-safety warnings and slowing approval times for new drugs, prompting charges that the FDA was over-reacting.

It’s not hard to find cases of FDA abuse. A May 1995 article in Reason discussed the case of Edwin Cohen, president of Barr Laboratories, who in 1989 testified before a congressional subcommittee about unfair treatment he had received from the FDA. Within hours FDA inspectors invaded Barr’s facilities in retaliation. Barr sued the agency repeatedly for relief from harassment, while it worked tirelessly to close him down. The company was hit with a blizzard of minor inspection violations and delays in drug approval. Its share price fell to one-sixth its former value. Production on several product lines was stopped, and one-quarter of the company’s employees were laid off. In 1993 Cohen was replaced by someone more agreeable to the FDA.

Articles in Life Extension (May 2001 and April 2002) describe the case of Durk Pearson and Sandy Shaw, who have been battling the FDA since 1994 for permission to sell folic acid with a label which includes the claim that the supplement is more effective than food sources of the vitamin in reducing the risk of neural-tube defects. The claim is well established in the medical literature and supported by the Institutes of Medicine and the National Academy of Sciences. In 1999, after years of bureaucratic delay, Pearson and Shaw sued the FDA. In an 11–0 decision, a federal appellate court ruled that the FDA had unconstitutionally suppressed this health claim. The FDA ignored the ruling and refused to authorize the claim, eventually issuing a regulatory ruling that it was “inherently misleading.” Pearson and Shaw sued the FDA again to force it to comply with the court’s previous ruling. In 2001 the court ruled that the FDA’s health-claim standard was arbitrary and capricious. District Court Judge Gladys Kessler found the FDA’s failure to comply with the earlier decision inexcusable and indicated she thought the plaintiffs and the public had been harmed. One survey showed that only 30 percent of women of childbearing age knew that folic acid reduces birth defects. By suppressing this information, the FDA had condemned thousands of babies to crippling birth defects.

For years the FDA refused to allow manufacturers to advertise the cardiovascular benefits of aspirin, despite clinical studies that supported the claim, resulting in the premature deaths of many thousands of people. Regular aspirin use slightly increases the risk of stroke for some, and the FDA was worried that this risk would be overlooked by consumers. As Paul H. Ruben explains: “This behavior is typical of the agency. It invariably places a much greater weight on any potential harm from a drug than on any benefit.”

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I tend to think the FDA is more the issue here and not the patent system.

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We can limit the patents to the compounds and end this foolishness of patenting old compounds for new uses.

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It’s not hard to find cases of FDA abuse.

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Well the patent as it applies to drugs that needs to be change is the patentability of new uses of generic compounds---particularly the granting of patents AND/OR patent like protection on compounds being used for the very same use as the applicant is applying for in other countries.

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No where else in chemistry does that exists. You can't patent a new use of nylon or of kevlar that I know of

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you most certainly can. You can't patent the Kevlar or nylon but you damn f****** sure can patent the fact you figured out how to use Kevlar to make parachutes that can't have holes shot through them

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