Healthy Skepticism Library item: 898

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

Publication type: news

Wilde MATHEWS.
FDA to Revamp Disclosure Process
THE WALL STREET JOURNAL 2005 Mar 18

Full text:

The Food and Drug Administration plans to revamp its process for disclosing potential conflicts of interest among members of its advisory committees, acting commissioner Lester Crawford said.

At his confirmation hearing to be the permanent head of the FDA, Dr.
Crawford said the agency will change disclosure procedures. “There should be easier disclosure,” he told the Senate Committee on Health, Education, Labor and Pensions. Later, a spokeswoman said the FDA is “reviewing ways to make our current process for providing disclosures more transparent and readily available to the public.”

Responding to Democrats’ queries about a bid by Barr Pharmaceuticals Inc. to sell emergency contraceptive Plan B over-the-counter, Dr. Crawford said the agency would make a decision within weeks.

The FDA gave details of its approval of Symlin, a diabetes drug that had raised safety concerns because it is tied to an increased risk of hypoglycemia, or low blood sugar. In 2001, an FDA advisory committee rejected the drug, made by Amylin Pharmaceuticals Inc., largely because of such concerns, though it did find the medication helped to control diabetics’ blood sugar.

Since then, the agency said, new data clarified conditions under which Symlin posed a risk and the approval came with provisions to minimize safety issues. Along with stringent labeling that recommends use by a limited population of patients, the drug will have no direct-to-consumer ads.

David Orloff, who directs the FDA division overseeing diabetes treatments, said Symlin, “while clearly benefiting some patients…is not for all patients.” Daniel Bradbury, chief operating officer for Amylin, San Diego, said the company “believes that these provisions provide a very comprehensive platform for managing risks associated with the product and at the same time providing the benefit.”