Headlines: February 15, 2010
by Meg Larkin
First, in policy news, the 2012 White House Budget Blueprint includes a number of proposals to speed the availability of generic drugs. Among other things, the budget would allow the Federal Trade Commission to prevent settlements between brand name pharmaceutical companies and generic drug manufacturers when the litigation, if successful, would enable earlier price competition from generic drugs. Another proposal in the budget would allow generic competitors to enter the market for biologic drugs after only 7 years, down from 12. The Pharmaceutical Research and Manufacturers of America have criticized both proposals as diminishing “incentives for future medical innovations.” The Generic Pharmaceutical Association supported the reduction in market exclusivity for biologics, but called the FTC proposal “misguided.” It is unclear how much money the ban on settlements would save, but the administration has asserted that the figure is about $8.79 billion over 10 years.
In regulatory news, a new study has called into question the FDA’s device approval system. An analysis reported Monday in the Archives of Internal Medicine, examined the 113 devices subject to FDA recalls between 2005 and 2009 and found that 71 percent of those devices had received agency approval without having to undergo testing in humans. The devices were recalled because they posed serious health risks to patients. The devices in question were allowed to go to market without being tested in humans because they were approved under a fast-track procedure for devices that are substantially similar to ones that have already been approved. FDA officials pointed out that most devices on the market, whether subject to recall or not, were approved under the accelerated process, questioning the impact of the study’s findings. The agency also pointed out that it has recently reviewed the accelerated approval program and is in the process of making changes to improve it. Device manufacturers dismissed the study’s findings, claiming the real problem is the delay that FDA approval causes in getting devices to market.
In research and regulatory news, some scientists are questioning the safety and efficacy of surgical interventions to treat psychiatric disorders. Recently, psychosurgery has been regaining popularity as a treatment option for patients with severe and intractable mental disorders. In 2009, one surgical technique received government approval for use in treating patients with severe obsessive compulsive disorder, but in a paper in the current issue of health affairs, some experts have said that decision was a mistake. According to the New York Times, “They argue that the surgery has not been sufficiently tested, that neither its long-term effectiveness nor its side effects are well known and that even calling it “therapy” raises people’s hopes well beyond what is scientifically supportable.” The paper has sparked a debate about whether surgery should be available as an option for patients with severe mental disorders when studies examining its long term effects as well as safety and efficacy have not been completed.
Finally, in research news, a fiber and plant rich diet could contribute to longevity. The Boston Globe reported that, in a study released by the National Cancer Institute, “researchers found that those ages 50 to 71 who ate at least 26 grams of fiber a day had a 22 percent lower risk of dying over 9 years compared with those who ate 13 grams of fiber a day or less.” Although study participants with high fiber diets were more likely to have an overall healthier lifestyle, the benefits of fiber were apparent even after these differences were accounted for. The findings support the recent USDA dietary recommendations, which encourage Americans to eat more fruits, vegetables, and whole grains while cutting down on meat and processed foods.
Meg Larkin is a third year law student at Boston University. Please feel free to email her with any questions, comments, suggestions or concerns.