health

"Plan B" flap leaves FDA nominee in limbo

Democrats grilled the agency's acting commissioner on what they perceive as the intrusion of ideology into the scientific work of the FDA.

By Susan J. Landers — Posted Aug. 21, 2006

Print  |   Email  |   Respond  |   Reprints  |   Like Facebook  |   Share Twitter  |   Tweet Linkedin

Controversy surrounding federal handling of the application for over-the-counter status of the emergency contraceptive pill known as Plan B landed Acting Food and Drug Administration Commissioner Andrew C. von Eschenbach, MD, in hot water during a Senate hearing over his nomination to permanently fill the post.

The FDA on July 31 announced a "framework" to speed approval of the OTC status of the emergency contraceptive, which was recommended nearly three years ago by the agency's advisory committee. Several groups, including the AMA, have urged forward movement on OTC approval since then.

Despite the new framework, Dr. von Eschenbach's status remained unchanged after the Aug. 1 hearing. Sens. Hillary Rodham Clinton (D, N.Y.) and Patty Murray (D, Wash.), proponents for the drug's OTC availability, placed a hold on the nominee's approval last spring until the FDA made a decision on levonorgestrel. Both said after the hearing that the hold would remain in place because the agency provided no timeline for action.

Although the FDA said approval under its new framework could come in a matter of weeks, a similar promise was made by former FDA Commissioner Lester M. Crawford, DVM, PhD, at his confirmation hearing last summer. Dr. Crawford left the agency soon after.

The AMA adopted policy in 2004 urging the FDA to move forward with OTC status for the contraceptive. Until that happens, the Association encourages physicians to write advance prescriptions for patients. Plan B must be taken within 72 hours of intercourse to be effective.

Clinton and other Democratic senators also grilled Dr. von Eschenbach about Bush administration actions that they view as politicizing a scientific agency. "This is a dangerous, slippery slope we're on, doctor, and we're looking to you to get a decision made," said Clinton.

Despite the Senate hold, some predict that President Bush may appoint his nominee to the post during Congress' August recess.

Back to top


ADVERTISEMENT

ADVERTISE HERE


Featured
Read story

Confronting bias against obese patients

Medical educators are starting to raise awareness about how weight-related stigma can impair patient-physician communication and the treatment of obesity. Read story


Read story

Goodbye

American Medical News is ceasing publication after 55 years of serving physicians by keeping them informed of their rapidly changing profession. Read story


Read story

Policing medical practice employees after work

Doctors can try to regulate staff actions outside the office, but they must watch what they try to stamp out and how they do it. Read story


Read story

Diabetes prevention: Set on a course for lifestyle change

The YMCA's evidence-based program is helping prediabetic patients eat right, get active and lose weight. Read story


Read story

Medicaid's muddled preventive care picture

The health system reform law promises no-cost coverage of a lengthy list of screenings and other prevention services, but some beneficiaries still might miss out. Read story


Read story

How to get tax breaks for your medical practice

Federal, state and local governments offer doctors incentives because practices are recognized as economic engines. But physicians must know how and where to find them. Read story


Read story

Advance pay ACOs: A down payment on Medicare's future

Accountable care organizations that pay doctors up-front bring practice improvements, but it's unclear yet if program actuaries will see a return on investment. Read story


Read story

Physician liability: Your team, your legal risk

When health care team members drop the ball, it's often doctors who end up in court. How can physicians improve such care and avoid risks? Read story

  • Stay informed
  • Twitter
  • Facebook
  • RSS
  • LinkedIn