Featured Research

from universities, journals, and other organizations

Internists Call For Increased Role For FDA

Date:
September 24, 2009
Source:
American College of Physicians
Summary:
A new policy paper that calls for broader authority and increased funding for the Food and Drug Administration was released today by the American College of Physicians. Improving FDA Regulation of Prescription Drugs offers a half-dozen recommendations about how to improve the agency's ability to approve and monitor new drugs.

A new policy paper that calls for broader authority and increased funding for the Food and Drug Administration (FDA) was released today by the American College of Physicians (ACP). Improving FDA Regulation of Prescription Drugs offers a half-dozen recommendations about how to improve the agency’s ability to approve and monitor new drugs.

The paper notes that the FDA has been chronically underfunded, has limited regulatory authority, and insufficient organizational structure to effectively undertake the complex task of regulating the safety and effectiveness of new and approved drugs. This regulating includes reviewing proposals for conducting clinical drug trials, evaluating drug applications and proposed drug labeling, and monitoring drugs once they are approved and marketed.

“The FDA is critical in assuring the prescription drugs available in this country are safe and effective,” said Joseph W. Stubbs, MD, FACP, president of ACP. “Unfortunately they have not historically been given the support and structure necessary to be optimally effective.”

In 2005, the FDA requested that the Institute of Medicine put together a committee to assess the current state of the U.S. drug safety system and to make recommendations to improve that system. The committee found that FDA’s ability to approve and monitor drug safety had been compromised by a lack of regulatory authority, long-standing underfunding, organizational problems, and a lack of postmarketing data on the effectiveness and safety of drugs. Since the report was issued the agency has taken steps to improve, however problems still remain.

In order to effectively improve the agency’s ability to regulate drugs, ACP recommends that the FDA:

  • be given increased funding;
  • increase their capacity to regulate drugs manufactured outside the U.S. through appropriations and user fees;
  • be given expanded authority to exercise in the design of preapproval trials and studies;
  • prohibit the bundling of drugs that limits marketability and availability;
  • improve the adverse events reporting system; and,
  • be given the authority to require new drugs be labeled with a symbol that indicates it is a new drug and that direct-to-consumer advertising be limited for the first two years after a drug’s approval.

“Physicians and our patients expect that the medications we prescribe and use are beneficial and will not cause significant harm,” concluded Dr. Stubbs. “I believe that using the recommendations we have provided today will allow us all to be more secure in that expectation.”


Story Source:

The above story is based on materials provided by American College of Physicians. Note: Materials may be edited for content and length.


Cite This Page:

American College of Physicians. "Internists Call For Increased Role For FDA." ScienceDaily. ScienceDaily, 24 September 2009. <www.sciencedaily.com/releases/2009/09/090924112843.htm>.
American College of Physicians. (2009, September 24). Internists Call For Increased Role For FDA. ScienceDaily. Retrieved October 21, 2014 from www.sciencedaily.com/releases/2009/09/090924112843.htm
American College of Physicians. "Internists Call For Increased Role For FDA." ScienceDaily. www.sciencedaily.com/releases/2009/09/090924112843.htm (accessed October 21, 2014).

Share This



More Health & Medicine News

Tuesday, October 21, 2014

Featured Research

from universities, journals, and other organizations


Featured Videos

from AP, Reuters, AFP, and other news services

CDC Revamps Ebola Guidelines After Criticism

CDC Revamps Ebola Guidelines After Criticism

Newsy (Oct. 21, 2014) The Centers for Disease Control and Prevention have issued new protocols for healthcare workers interacting with Ebola patients. Video provided by Newsy
Powered by NewsLook.com
WHO: Ebola Vaccine Trials to Start a in January

WHO: Ebola Vaccine Trials to Start a in January

AP (Oct. 21, 2014) Tens of thousands of doses of experimental Ebola vaccines could be available for "real-world" testing in West Africa as soon as January as long as they are deemed safe in soon to start trials, the World Health Organization said Tuesday. (Oct. 21) Video provided by AP
Powered by NewsLook.com
First-Of-Its-Kind Treatment Gives Man Ability To Walk Again

First-Of-Its-Kind Treatment Gives Man Ability To Walk Again

Newsy (Oct. 21, 2014) A medical team has for the first time given a man the ability to walk again after transplanting cells from his brain onto his severed spinal cord. Video provided by Newsy
Powered by NewsLook.com
CDC Issues New Ebola Guidelines for Health Workers

CDC Issues New Ebola Guidelines for Health Workers

Reuters - US Online Video (Oct. 21, 2014) The U.S. Centers for Disease Control and Prevention has set up new guidelines for health workers taking care of patients infected with Ebola. Linda So reports. Video provided by Reuters
Powered by NewsLook.com

Search ScienceDaily

Number of stories in archives: 140,361

Find with keyword(s):
Enter a keyword or phrase to search ScienceDaily for related topics and research stories.

Save/Print:
Share:

Breaking News:

Strange & Offbeat Stories


Health & Medicine

Mind & Brain

Living & Well

In Other News

... from NewsDaily.com

Science News

Health News

Environment News

Technology News



Save/Print:
Share:

Free Subscriptions


Get the latest science news with ScienceDaily's free email newsletters, updated daily and weekly. Or view hourly updated newsfeeds in your RSS reader:

Get Social & Mobile


Keep up to date with the latest news from ScienceDaily via social networks and mobile apps:

Have Feedback?


Tell us what you think of ScienceDaily -- we welcome both positive and negative comments. Have any problems using the site? Questions?
Mobile: iPhone Android Web
Follow: Facebook Twitter Google+
Subscribe: RSS Feeds Email Newsletters
Latest Headlines Health & Medicine Mind & Brain Space & Time Matter & Energy Computers & Math Plants & Animals Earth & Climate Fossils & Ruins