Call Us: 1.800.873.5297


The FDA and Drug Approval

The United States Food and Drug Administration (FDA) is charged with ensuring the efficacy and safety of many different products, many of which are drugs and medical devices. Once a drug is approved by the FDA, consumers like to believe the drug is safe. Unfortunately, however, that is not always the case. You will often hear news reports about drugs being recalled or being issued a “black box warning,” (the most serious warning a drug can be given by the FDA before being recalled) even after receiving FDA approval. What many people may not realize is that the FDA is not responsible for conducting its own trials of the drugs it approves for sale.

In legal speak, the FDA was given legal authority by the Federal Food and Drug Act of 1938 to “review and approve new drugs for sale in the United States based on scientific support provided by the drug manufacturer as to the safety and efficacy of the drug or medical device.”

After testing a drug, the drug manufacturer sends the FDA an application known as a “New Drug Application.” If a review by the FDA’s physicians indicates the drug’s benefits outweigh the known risks, the drug is approved and marketed. When the FDA discovers that a drug maker has violated FDA regulations, the FDA will send a warning letter to the drug company identifying the violation(s) and orders the company to correct the problems. The FDA then follows up to make sure the corrections were made. If they were not, the drug could be recalled or be issued a black box warning.

The FDA is not responsible for creating the warning labels on medications; the pharmaceutical companies have this responsibility. The problem lies in the fact that sometimes, drug manufacturers do not fully comply with their obligations to ensure the products they put on shelves are safe and effective. When this responsibility is shirked, people can get very sick and die due to adverse effects from the drugs they were prescribed. When lives are lost or people are made seriously ill from dangerous drugs, lawsuits can be filed against the drug manufacturer and other parties involved in providing the drug to the victim.

Many claim there are problems with the FDA-approval process of drugs and medical devices. One major claim against the approval process is that drugs are often approved after only short clinical trials, which means that long-term effects of the drug cannot be detected. Drug companies are supposed to perform studies after the drug hits the market, but many of these companies simply do not follow through with these studies because the FDA has little power after a drug is approved.

The FDA approval process for drugs and medical devices is a complicated one that cannot possibly be explained fully here. To learn more about this process, please read our page FDA Approval Process & the Pharmaceutical Manufacturers.

If you or a loved one has been harmed by a dangerous drug, an experienced defective drug attorney can review your case and advise you of how to proceed. Please contact Schlichter, Bogard & Denton today to schedule a confidential consultation.

000-017   000-080   000-089   000-104   000-105   000-106   070-461   100-101   100-105  , 100-105  , 101   101-400   102-400   1V0-601   1Y0-201   1Z0-051   1Z0-060   1Z0-061   1Z0-144   1z0-434   1Z0-803   1Z0-804   1z0-808   200-101   200-120   200-125  , 200-125  , 200-310   200-355   210-060   210-065   210-260   220-801   220-802   220-901   220-902   2V0-620   2V0-621   2V0-621D   300-070   300-075   300-101   300-115   300-135   3002   300-206   300-208   300-209   300-320   350-001   350-018   350-029   350-030   350-050   350-060   350-080   352-001   400-051   400-101   400-201   500-260   640-692   640-911   640-916   642-732   642-999   700-501   70-177   70-178   70-243   70-246   70-270   70-346   70-347   70-410   70-411   70-412   70-413   70-417   70-461   70-462   70-463   70-480   70-483   70-486   70-487   70-488   70-532   70-533   70-534   70-980   74-678   810-403   9A0-385   9L0-012   9L0-066   ADM-201   AWS-SYSOPS   C_TFIN52_66   c2010-652   c2010-657   CAP   CAS-002   CCA-500   CISM   CISSP   CRISC   EX200   EX300   HP0-S42   ICBB   ICGB   ITILFND   JK0-022   JN0-102   JN0-360   LX0-103   LX0-104   M70-101   MB2-704   MB2-707   MB5-705   MB6-703   N10-006   NS0-157   NSE4   OG0-091   OG0-093   PEGACPBA71V1   PMP   PR000041   SSCP   SY0-401   VCP550  

Legal Disclaimer & Privacy Policy
This web site is designed for general information only. The information presented should not be construed as legal advice and does not form the basis for an attorney/client relationship.

The choice of a lawyer is an important decision and should not be based solely on advertisements.
This web site is not intended to be advertising, and Schlichter Bogard & Denton LLP does not desire to represent anyone desiring representation based upon viewing this web site in a jurisdiction where this web site fails to comply with all laws and ethical rules of that jurisdiction. Materials on this web site may only be reproduced in their entirety (without modification) for the individual reader's personal and/or educational use and must include this notice.

We will not disclose, sell, or rent any of your identifiable personal information to any third party, unless approved by you, or required by law.