Concerns about regulatory agencies' abilities to protect the public are not unique to FDA or public health. Two regulatory frameworks exist for the review of prescription drugs. First, FDA reviews the safety and effectiveness of new drugs that manufacturers wish to market in the United States; this process is called premarket approval or preapproval review . Once a drug has passed that threshold and is FDA-approved , FDA acts through its postmarket or post-approval regulatory procedures. The Current System

A drug cannot be marketed in the United States without FDA approval, for which the manufacturer must demonstrate the drug's safety and effectiveness to FDA's satisfaction, see its manufacturing plant pass FDA inspection, and obtain FDA approval for the drug's labeling—a term that includes all written and electronic material about the drug, including packaging, prescribing information for physicians, and patient brochures. If there is no objection, a manufacturer may begin clinical testing after that time. Manufacturers must report all serious and unexpected adverse reactions within 15 days of becoming aware of them (21 C.F.R. That said, the six areas around which most recommendations revolve are:
FDA organization FDA budget Role of industry Opportunities to use the drug approval process to enhance postmarket activities Insufficient postmarket information Lack of public access to available data
Some of the proposed changes lie within FDA's legislative authority to implement. Others would require congressional action. The IOM Committee on the Assessment of the U. S. Drug Safety System issued its report in September 2006. Opportunities to Use the Drug Approval Process to Enhance Postmarket Activities

Aside from whether FDA is wholly independent, there is broad agreement among those who have looked closely at FDA's process for drug approval that a number of specific changes in the evaluation process could make FDA more likely to anticipate, identify, and handle problems in ensuring the safety and effectiveness of drugs. FDA reports industry-committed study status annually in the Federal Register , but many feel that not only does FDA not have adequate authority to compel compliance, it does not sufficiently follow through with the tools it does have to enforce those commitments. What are the limitations of a passive approach? In this 100 th year of the Food and Drug Administration, Congress is clearly poised to examine whether FDA needs more legal authority to regulate the safety and effectiveness of drugs.
COX-2 inhibitors and SSRIs—the 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 drugs—used primarily to treat pain and depression—have 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 testing—studies in which humans take the investigational new drug in carefully controlled, and usually randomized, trials—from 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.