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Selected news articles which highlight important policy issues.

News: Weekly Archives

News for the week of 06-08-2006

Watching the watchdog
The Boston Globe, 6-8-06

Editor's Notes:

Senator Charles Grassley has earned plenty of media attention for his "get tough" approach to the FDA—and 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 whistle–blowers, Grassley says he is trying to prod the agency to change a culture that stifles and punishes dissenters. He has exposed internal FDA memos, e–mails, and conversations to unprecedented public scrutiny. Sunlight, he is fond of saying, "is the best disinfectant."

Wyoming Republican Senator Michael Enzi, whose committee is supposed to take the lead on FDA oversight, says he is not threatened by Grassley's flurry of letters, press conferences, and congressional hearings. "I don't care who looks into what, it's fine," said Enzi, chairman of the Senate Health, Education, Labor, and Pensions Committee.

Grassley said the FDA watchdog role is natural for him as Senate Finance chairman with oversight over Medicare, a program that spends heavily on prescription drugs. "I've got absolutely every reason in the world to make sure that the Medicare tax dollar buys a safe and effective drug," he said.

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 drug–safety barriers."

The full picture is probably less unsavory than all of the talk of whistle–blowers 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 effective—a 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.

[permanent link]

FDA Announces New Measures to Protect Americans from Counterfeit Drugs
FDA News, 6-9-06

Editor's Notes:

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 products—the so–called "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.

Further, FDA has not heard that the concerns raised in the past regarding the impact on small wholesalers remains, and in fact, FDA was encouraged by most drug stakeholders to allow the hold to expire. Doing so would also provide clarity in the drug supply chain regarding who is and is not required to pass a pedigree. Continuing the hold would perpetuate the current confusion and further allow opportunities for counterfeit and diversionary practices. FDA has, therefore, determined that it can no longer justify not implementing these regulations.

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 non–fiction 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 encouraging—but 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 low–life 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."

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U.S. Approves Use of Vaccine for Cervical Cancer
The New York Times, 6-9-06

Editor's Notes:

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.

Federal vaccine experts are widely expected to recommend that all 11– to–12–year–old girls get the vaccine, but its reach could be limited by its high price and religious objections to its use. Merck, Gardasil's maker, said a full, three-shot course would cost $360, making Gardasil among the most expensive vaccines ever made.

"This is a huge advance," said Dr. Jesse Goodman, director of the Food and Drug Administration's biologics center. "It demonstrates that vaccines can work beyond childhood diseases to protect the health of adults."

The vaccine prevents lasting infections with two human papillomavirus strains that cause 70 percent of cancers and another two strains that cause 90 percent of genital warts. But if girls have already been exposed to those strains, the vaccine has no effect, so health experts want the vaccine given before girls have sex. The median age at which girls have sex is 15.

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.

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Going from the lab to Limbo: The FDA has been delaying decisions on applications, and drugmakers are fuming
Business Week, 6-12-06

Editor's Notes:

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."

These awkwardly named "approvable" letters are not uncommon—there have been more than 10 since the beginning of the year. The indiplon case caused considerable grumbling in the pharma industry, however. Such letters can be provoked by safety and efficacy issues or minor concerns about the wording of the medicine's label. This time, says Neurocrine, the approvable verdict was issued because the FDA didn't have time to review the data.

Not enough time? Dr. John Jenkins, head of the FDA's Office of New Drugs would not comment directly on indiplon, but he did say that "a company may amend an application with a new study that comes in fairly late in the review process." In other words, the agency can get swamped—and in January, Neurocrine was still submitting results requested by the FDA.

The indiplon case is seen by some FDA watchers as part of a worrisome slowdown at the agency, at a time when the industry is already suffering from a malaise of its own making. A dearth of promising drugs in the pipeline and safety concerns about drugs already on the market have sent pharma and biotech stock prices into a trough. Even the upcoming American Society of Clinical Oncology (ASCO) meeting, in Atlanta June 2–6, is a bit of a downer. The meeting had beamed a flattering light on the pharma industry the past few years by showcasing major advances against cancer. This year, no such announcements are expected.

Amid all this comes the FDA's version of a time–out. By law, the agency must reach some kind of decision within 6 to 10 months of a new drug filing; an approvable letter, however, wins the agency another two to six months after an application is refiled—and a refiling can take anywhere from months to years. Since the vast majority of these drugs go on to win approval, "I really don't get this," says Dr. Steven E. Nissen, a cardiologist at the Cleveland Clinic. He notes that the panels of outside experts that guide the FDA on drug applications always reach a decision by their deadlines. "I know [the FDA is] underfunded and understaffed, but a drug is either approvable or it's not. The approvable letter sends mixed messages."

It is actually becoming unusual for a new drug to avoid such an interim phase. And even as approvable notices have proliferated, the number of approvals has fallen, from 119 in 2004 to 80 last year. It's not just the lack of new applications. Agency watchers say the FDA has also become risk–averse as a result of the debacle over Merck & Co.'s (MRK ) painkiller, Vioxx, withdrawn in 2004. Writing about "safety signals" that might have been acceptable in the past, a First Albany Capital report notes: "The FDA's tolerance...appears to have declined," leading to "unsettling surprises."

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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