Plan B news from FierceBiotech

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 …

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. …

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 …

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.

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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 …

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 …

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 …

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 …

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 …

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 …