Howdy Partner. Here are some toplines from the very interesting week. If you missed things, be sure to see yesterday’s posting on Ketek Headaches and the fact that FDA was left out of the ABC News story. Or, see the day before about Dr. Lester Crawford’s testimony on Plan B and the many more questions that remain. In the meantime, in other news….
- Dr. Janet Woodcock’s Testimony on RU-486 Still Not Posted – The FDA still has not posted Dr. Woodcock’s testimony on this important issue, yet testimony offered by Daniel Schultz, M.D., Director,Center for Devices and Radiological Health from a hearing yesterday was posted. No answer to my request for information on this sent to FDA’s Webmaster. Curious.
- First Cervical Cancer Late Stage Treatment Approved – The agency approved a combination treatment for late stage cervical cancer that combines Hycamtin (topotecan hydrochloride) manufactured by GlaxoSmithKline and cisplatin.
- Dr. Gottlieb Gives Another Speech – This time before the AMA. Dr. Gottlieb continues to be the voice of FDA. Dr. von Eschenbach’s speech at the Center for Medicine in the Public Interest event, not posted. "If you agree with the premise that government is increasingly influencing ordinary clinical decisions previously left to doctors and patients, and I hear regularly from doctors who do, then I believe FDA has been both a part of the problem and can be part of the solution," he said. He talked about safety issues and the increasing calls for more involvement of government in the patient/physician relationship. Then he talked about the FDA’s new labeling effort.
- Medical Error Reduction Campaign – The agency announced a new campaign aimed at medical mistakes caused by confusing abbreviations used by doctors.
- The Blues in Winter Have a New Enemy – The FDA announced approval of Wellbutrin XL, manufactured by GlaxoSmithKline for prevention of major depressive episodes in patients with a history of seasonal affective disorder (SAD).
- Counterfeit Drug Effort – The agency also announced a renewed effort at strengthening protections against counterfeit drugs in the U.S. The agency said it will "fully implement"regulations related to the Prescription Drug Marketing Act of 1987. Now, drug distributors will be required to provide documentation of the chain of custody of drug products. The reason this had not been done before was based on a lack of technology, according to the press release.
- AMA Wants Waiting Period for Advertising – The American Medical Association has carved out a position that would create a waiting period from the time a drug is approved before it can be advertised to patients to afford time for the drug to be further studied. An interesting compromise to direct support of a ban on DTC, it would, if enacted, most surely result in an increased effort at public relations for drug launches.
Have a good weekend!