Plan B

Senate confirms von Eschenbach as chief of FDA

Thu, 07 Dec 2006 19:01:37 -0500

Andrew von Eschenbach gained the overwhelming support of the Senate in his long-delayed bid to become chief of the FDA. Senators supported his nomination by a vote of 80 to 11. Among the small band of opponents were several Republicans, including Senator Charles Grassley, who has been steaming over what he sees as a lack of cooperation at the agency in his investigation of the controversial antibiotic Ketek. Von Eschenbach has been acting head of the FDA for slightly more than a year now. During that time he erased a major obstacle to his confirmation by allowing access to Plan B, the morning after pill, without a prescription.

Von Eschenbach's confirmation as head of the FDA will likely trigger a collective sigh of relief in the drug development world. Over the past six years of the Bush administration, the agency has had an official chief for only 18 months. The previous head of the FDA resigned shortly after gaining confirmation to the office and was recently charged with a conflict of interest. Drug developers are looking to the FDA to deliver on the Critical Path Initiative and other projects aimed at streamlining the drug approval process. They're also wary of just how much new research work they'll be required to do on newly approved drugs as the FDA works to reassure a skeptical public that the drugs it approves are indeed safe. Von Eschenbach will play a major role in all of those decisions.

- here's the Washington Post's report on the vote
- read BIO's statement on von Eschenbach's confirmation

Related Articles:
Two Senators block von Eschenbach. Report
FDA clears way for Plan B to go OTC. Report
Investors anxious to see Eschenbach confirmed. Report

FDA's Crawford charged with lying about stock

Mon, 16 Oct 2006 20:01:36 -0400

The mystery that surrounded the sudden and unexplained departure of Lester Crawford shortly after his confirmation as FDA chief has cleared up. Crawford was charged yesterday with lying about the stocks he owned in companies regulated by the agency. Specifically, Crawford owned stock in Pepsi and Sysco at a time he chaired the FDA's Obesity Working Group, which made decisions about snack and soft drink products. And he had owned stock and been a member of the board of Embrex, an agricultural biotech company regulated by the FDA. The criminal charges brought by the Justice Department allege that Crawford lied about the shares, saying they had been sold. Crawford's attorney says he will plead guilty today to two misdemeanors: false writing and conflict of interest. Each charge carries a potential one-year jail sentence.

- here's the AP report on the charges
- and here's a report on the plea deal

Related Articles:
FDA's Crawford faces criminal investigation. Report
Crawford acknowledges role nixing Plan B. Report

Two Senators block von Eschenbach

Thu, 14 Sep 2006 20:01:37 -0400

Fresh from giving the green light on Plan B in order to satisfy two Democrats holding up the nomination of Andrew von Eschenbach to head the FDA, two Republican Senators now say they have demands of their own that will have to be met prior to his elevation to the post. Senator David Vitter is demanding that the government provides a compromise agreement on importing drugs from Canada and Senator Jim DeMent is demanding that the abortion drug RU-486 is taken off the market, according to a report in The New York Times. Neither action is likely anytime soon and Vitter is predicting that Eschenbach's nomination will remain in limbo until next year. Only yesterday, though, analysts were predicting clear sailing for his nomination in a vote scheduled for next week.

- check out the UPI's report on the demands

Barr takes cautious approach in marketing Plan B

Thu, 24 Aug 2006 20:01:36 -0400

An FDA approval of any kind is often the trigger to a massive advertising blitz, but ad experts say that Barr Pharmaceuticals is likely to stay focused on a discreet, tailored campaign while talking directly with healthcare professionals. Barr notes that the agreement with the FDA also limits sales of the contraceptive to pharmacies and clinics, so a major branding campaign hardly makes sense.

- read the article on Plan B from The Wall Street Journal (sub. req.)

ALSO: Despite the brouhaha over the OTC approval, most analysts say that Plan B will barely register on the radar of drug industry sales. Article

FDA clears Plan B, ending FDA confirmation fight

Wed, 23 Aug 2006 20:01:38 -0400

After three years of regulatory limbo, Barr Laboratories has won the right to market the Plan B contraceptive without a prescription. Women over 18 will be required to show proof of their age to buy the drug while under age girls will still need a prescription. Plan B has been a favorite cause on both sides of the political divide. Opponents say that OTC access of what it calls an "abortion pill" would encourage promiscuity and further spread sexually transmitted diseases while backers have insisted that the FDA had to approve the drug before they would allow Bush's nominee to run the agency gain official title to his office. In the end, the shift happened swiftly as Andrew von Eschenbach signaled a desire to deal with the controversy and move on. Resolving the impasse over Plan B is likely to swiftly lead to a Senate confirmation of his nomination.

- check out the article on Plan B from The Washington Post

Editor's Corner

Sun, 20 Aug 2006 20:01:40 -0400

On Friday Barr Laboratories resubmitted its application to make Plan B available without a prescription. Given the FDA's sudden willingness to work out a marketing plan for the contraceptive, Barr has a good shot at finally obtaining an approval that should have come through in 2004. More importantly, it's a chance for the FDA to demonstrate that science and not ideology dictates how it reviews a therapeutic. Given the Bush administration's clear preference for ideology, the FDA may have more difficulties ahead. But for now, there's reason for hope. - John Carroll

FEATURE: A Step in the Right Direction?

Thu, 17 Aug 2006 20:01:32 -0400

A Step in the Right Direction?

By Mike Scott

On November 14, 2002, Mark McClellan was appointed Commissioner of the U.S. Food and Drug Administration and held the position for 14 months. Lester Crawford was confirmed to replace Dr. McClellan on July 18, 2005, and held the office for just 2 months. Indeed, since David Kessler stepped down in February 1997 there has been a confirmed Commissioner of the FDA for less than 4 of the following 9 and a half years. This is not a track record to cheer about. And the stature of the FDA has suffered badly as a consequence.

No one who works in the U.S. biotechnology or pharmaceutical industries can be in much doubt today about the range of challenges facing any individual who holds the office of Commissioner. Not only did Dr. Kessler set a new standard for activism as a holder of this office, but the increasing attempts to influence the decisions of the FDA through political, legal, social, commercial, and other channels has made this position one of the most visible and perhaps unenviable public positions in modern US government. Indeed, the Commissioner commonly has greater name recognition than his or her superiors in the Department of Health and Human Services.

If one puts aside personal political views and accepts that the FDA "adheres to [four] fundamental principles that frame its actions and lead to more effective public health results," as stated on its Web site, it should be noted that the current Acting Commissioner, Andrew von Eschenbach, has made a strong start in seeking to fill the shoes of some of his more successful predecessors.

Dr. von Eschenbach has moved quickly to address one of the most difficult situations outstanding at the FDA: Barr Laboratories' application for approval of Plan B as an over-the-counter agent for the prevention of pregnancy. It may be that without such action, his ability to gain Congressional approval for his appointment would have proved impossible. It may be that, as a friend of the Bush family, he was able to persuade the Administration in the White House that such action was a political imperative.

One can think of a lot of such, "It may be's." The facts, however, speak volumes about Dr. von Eschenbach's apparent desire to make it clear that, under his leadership, the FDA will seek to be judged on the scientific validity of its decision-making process, even if a little compromise is necessary along the way.

The signs are now strong that Barr Laboratories will gain an approval to market Plan B as an over-the-counter agent available to any woman of 18 years or older. Women under the age of 18 will continue to require a prescription for this drug. Some may claim that this is still a "political" decision and that the FDA should have approved the availability of this agent for younger women as an OTC agent, as originally recommended by an FDA Advisory Committee. And of course such an approval will be a political decision but it would be a good political decision at a time when this nation is torn by strongly held emotional and religious beliefs not only about when life begins but also about when and how life can end. Plan B should become widely available to adults and younger persons will be required to seek some professional guidance associated with the product's use.

The pharmaceutical and biotechnology industries must take a strong stand alongside Dr Eschenbach in support of this decision. The nation is in desperate need of an individual who can and will bring real leadership to the FDA, and who can be relied on to place a premium on the importance of sound science as the imperative that will guide FDA decision-making for the foreseeable future. Small compromises may be necessary on occasion for all sorts of reasons, but good scientific evidence as the fundamental basis for action is the principle that will best benefit the American public and FDA-regulated industries.

Few of us will agree with every decision that Dr. von Eschenbach makes if he is confirmed as Commissioner, but most of us should agree that a strong Commissioner who takes decisive action is essential.

Mike Scott is a principal and executive vice president of Vox Medica, Inc., a Philadelphia-based group of healthcare communications companies.

FDA clears way for Plan B to go OTC

Tue, 08 Aug 2006 20:01:39 -0400

After a lengthy wait, the FDA and Barr Pharmaceuticals have come up with an agreement that clears the way for the over-the-counter sale of the contraceptive Plan B. Under the agreement, Barr will sell Plan B OTC to women over the age of 18 while women under that age will be required to have a prescription. The agency has been sitting on this decision for more than two years, leading several U.S. senators to vow to indefinitely hold up Dr. Andrew von Eschenbach's appointment to head the FDA until the impasse over Plan B was resolved. Conservative groups had fiercely opposed any agreement to allow Plan B to go OTC, calling it an abortion drug. Abortion rights groups, meanwhile, say Plan B would actually reduce the number of abortions in the U.S. The agreement marks a significant turning point for the FDA. With a plan now for Plan B, the FDA is likely to get Dr. von Eschenbach's appointment completed and the FDA can move on to other business.

- read the article on Plan B from The New York Times

FDA indicates it may allow Plan B to go OTC

Mon, 31 Jul 2006 20:01:39 -0400

In what could mark a major breakthrough in the impasse over Plan B, the FDA has indicated that it may move ahead and make the controversial contraceptive available over-the-counter for women 18 and older. In a letter to Barr Pharmaceuticals, the agency asked what steps could be taken to ensure that underage girls don't obtain it and that a final decision was being sought in a matter of weeks. The morning-after pill has proved to be a major stumbling block at the FDA. A number of Democrats in Congress vowed to hold up the confirmation of acting FDA Commissioner Andrew C. von Eschenbach until the agency pushed ahead and allowed Plan B to go OTC, as recommended two years ago by an agency advisory board. The FDA has been severely criticized both internally and externally for allowing politics to trump science in its decision-making process. Religious conservatives, meanwhile, vowed to keep up the fight, maintaining that Plan B could only promote promiscuity among teens.

- here's the article on Plan B from the Los Angeles Times

Poll finds problems at the FDA

Thu, 20 Jul 2006 20:01:38 -0400

A study released by the Union of Concerned Scientists has found that about 15 percent of FDA staffers polled say they've been "asked to… inappropriately exclude or alter technical information or conclusions in an FDA scientific document." In addition, 39 percent of respondents stated that the FDA wasn't "acting effectively to protect public health." The questionnaire was sent to almost 6,000 FDA workers and 997 responded.

The survey underscores critics concerns that the science isn't the only factor that informs the FDA's decisions. The agency has taken heat for the Vioxx debacle, and a head women's health official resigned in protest to the way politics interfered with science in the FDA's handling of Plan B, a controversial morning-after contraceptive. A spokeswoman for the FDA dismissed the poll, saying it was unscientific and asked leading questions.

- check out this San Francisco Chronicle article