Health

Pediatric drugs get labeling changes

NEWS IN BRIEF — Posted April 16, 2007

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

A majority of the drugs -- about 87% -- that have been granted exclusivity under the Best Pharmaceuticals for Children Act have had important labeling changes as a result of the drug studies conducted under the law, according to a Government Accountability Office report.

The report, released March 22, also found that drug sponsors had agreed to 173 of the 214 requests for pediatric studies made by the Food and Drug Administration.

The BPCA, enacted in 2002, allows the manufacturers of drugs that are still on patent to conduct pediatric studies. If they do so, the FDA could extend their right to market the drug without generic competition for six additional months.

The GAO report also found that the label change process was lengthy, taking from 238 to 1,055 days for information to be reviewed and changes to be approved for 18 drugs, or about 40% of those referred as of December 2005. Label changes took more than a year for seven of the drugs.

Note: This item originally appeared at http://www.ama-assn.org/amednews/2007/04/16/hlbf0416.htm.

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