Drug Safety and Effectiveness: Issues and Action Options After FDA Approval (CRS Report for Congress)
Premium Purchase PDF for $24.95 (40 pages)
add to cart or
subscribe for unlimited access
Pro Premium subscribers have free access to our full library of CRS reports.
Subscribe today, or
request a demo to learn more.
| Release Date |
Revised Jan. 24, 2007 |
| Report Number |
RL32797 |
| Report Type |
Report |
| Authors |
Susan Thaul, Domestic Social Policy Division |
| Source Agency |
Congressional Research Service |
| Older Revisions |
-
Premium March 8, 2005 (36 pages, $24.95)
add
|
Summary:
COX-2 inhibitors and SSRIsâthe U.S. public has become more familiar with these technical abbreviations for biochemical processes than one might expect from our general level of science knowledge. Safety concerns about these drugsâused primarily to treat pain and depressionâhave turned a spotlight on the Food and Drug Administration (FDA) and its approach to protecting the public from drug risks that had not been identified before FDA-approval allowed the drugs on the market.
Two regulatory frameworks exist for the review of prescription drugs. First, in the premarket approval process, FDA reviews the safety and effectiveness of new drugs that manufacturers wish to market in the United States. A large part of this review is FDA's examining the manufacturer-provided data from clinical testingâstudies in which humans take the investigational new drug in carefully controlled, and usually randomized, trialsâfrom progressively larger Phase I, II, and III trials.
Second, after a manufacturer has sufficiently demonstrated a drug's safety and effectiveness for a defined population and specified conditions, and the drug is FDA-approved, FDA acts through its postmarket regulatory procedures. Manufacturers must report all serious and unexpected adverse reactions to FDA and clinicians and patients may do so.
The law gives FDA authority to take limited action if it finds a drug's post-approval use presents an increased risk of an adverse event. However, many suggest that not only does FDA need a broader range of enforcement tools, but that FDA also is not taking full advantage of the authority it does have.
While critics of FDA differ in their assessment of what is wrong with FDA's approach to postmarket safety activities, there is broad agreement that it needs significant change. Discussion of the problems and possible solutions revolves around six areas: FDA organization, FDA budget, role of industry, opportunities to use the drug approval process to enhance postmarket activities, insufficient postmarket information, and lack of public access to available data. Some of the proposed changes lie within the power of FDA to implement. Others would require congressional action.
This report examines various options for strengthening FDA's ability to protect the public. It will be updated from time to time to reflect legislative action by Congress.
