|Selected news articles which highlight important policy issues.||
News: Weekly Archives
News for the week of 06-08-2006
Watching the watchdog
Senator Charles Grassley has earned plenty of media attention for his "get tough" approach to the FDAand he is also the sponsor of legislation that would create an independent "Office of Drug Safety" at the FDA, which would have wide powers to pull drugs from the market or mandate new safety studies beyond those required by the agency.
Armed with insider information from whistleblowers, Grassley says he is trying to prod the agency to change a culture that stifles and punishes dissenters. He has exposed internal FDA memos, emails, and conversations to unprecedented public scrutiny. Sunlight, he is fond of saying, "is the best disinfectant."
However, a former FDA associate commissioner, William Hubbard, told the Globe that, although he thought that the Senator was "well meaning," he didn't think that the Senator "really has a full understanding of the drugsafety barriers."
The full picture is probably less unsavory than all of the talk of whistleblowers suggests. The FDA has to reach a binary judgment on new drugs: to approve or not approve. But every drug has side effects, from serious to not so serious, which can provoke genuine disagreement between FDA reviewers.
The question then, is not whether a drug is "safe" (and no drug is safe for everyone) or effective (ditto) but whether or not the drug is reasonably safe and effectivea judgment that, the majority of the time, is best made by a physician and a patient when all of the relevant information is taken into account.
And, of course, whistleblowers gain all the glory, but when was the last time you read a story about an FDA reviewer who approved a medicine despite safety concerns which eventually turned out to be a life saving medicine? These stories undoubtedly exist, but they aren't very media friendly.
Last week the FDA announced a new initiative that will help reduce the risk of Americans being exposed to dangerous or ineffective counterfeit prescription drugs.
Among other new measures, FDA will fully implement regulations related to the Prescription Drug Marketing Act of 1987, which requires drug distributors to provide documentation of the chain of custody of drug productsthe socalled "pedigree"throughout the distribution system. FDA had placed on hold certain regulatory provisions because of concerns raised at the time about the impact on small wholesalers. Most recently, in early 2004, FDA delayed the effective date of certain regulatory provisions regarding pedigrees to allow the industry time to adopt electronic technology for tracking drugs through the supply chain. Based on information from drug supply stakeholders, the FDA had expected this technology to be in widespread use in the drug supply chain by 2007, but it now appears that these expectations will not be met.
The new regulations will take effect in December 2006. For new comers to the issue of how counterfeit drugs enter the legitimate supply chain, there is no better introduction than investigative reporter Katherine Eban's sobering nonfiction expose Dangerous Doses, which chronicles the growing black market for fake and diluted prescription drugs. When contacted about the change in FDA policy, Eban was encouragingbut felt that more still needed to be done:
"For decades, the nation's drug supply has been run on an honor system, with minimal oversight and only a hodge podge of state laws to protect patients. The result: criminals from lowlife opportunists to narcotics traffickers have become pharmaceutical wholesalers and manufacturers, moving adulterated medicine into our trusted pharmacies and hospitals. Though more is needed, the FDA's announcement is an important first step in restoring the integrity of the drug supply."
U.S. Approves Use of Vaccine for Cervical Cancer
The FDA recently approved a new vaccine against the virus (HPV) that is responsible for the vast majority of cervical cancer cases in the U.S. and around the globe. If the vaccine is widely accepted, it has the potential to save hundreds of thousands of lives, particularly in developing countries.
The vaccine, called Gardasil, guards against cancer and genital warts caused by the human papillomavirus, the most common sexually transmitted disease. It is the culmination of a 15–year effort that began at the National Cancer Institute and a research center in Australia, and health officials described the vaccine as a landmark.
The vaccine may be expensive—but so were the trials required for its approval, Merck tested the vaccine in 25,000 patients in 33 different countries. The cost of the vaccine is likely to be outweighed by a reduction in the number of cases of cervical cancer, particularly in the developing world, where it is likely to be sold at a steep discount.
As a counterpoint to the Boston Globe article on Senator Grassley's attempts to "rein in" the FDA, BusinessWeek offers a picture of FDA reviewers who are increasingly delaying the approval of new drugs in order to get more data. Is this a bad thing? Only for patients in need of new medicines—which means, essentially, all of us.
Shares of Neurocrine Biosciences Inc. (NBIX ) plunged 62% in one day last month, wiping out more than $1 billion worth of shareholder equity. The fire sale was ignited by an unexpected action by the Food & Drug Administration on Neurocrine's application for a new insomnia drug, indiplon. Do not assume, however, that the FDA rejected the drug. For the three different doses of indiplon under consideration it issued two "approvable" letters and one "non–approvable" letter. In other words, two "maybes," one "probably not."
The difference again, is that while there is plenty of media coverage of whistleblowers alleging FDA indifference, there is little government outrage over the absence of new therapies. And here lies the disjuncture: how do you measure the loss of something that you have never seen?
Almost all of the incentives at the FDA push it to weight safety more heavily than innovation. Getting the right balance between safety and innovation is important, but this balance is impossible to find if you can’t establish meaningful variables for comparison.
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