In 2013, the U.S. Food and Drug Administration approved 27 new novel drugs. According to the organization, the number of applications for such drugs, which often undergo clinical trials, has remained steady. As a Reno prescription drug lawyer may know, many manufacturers do not seek FDA guidance regarding their clinical trials. Not only does this do a disservice to the drug maker, but it can also prove to end up creating inefficiencies in the way harmful drugs are discredited and effective drugs are approved.
How a clinical trial works
Generally speaking, biopharmaceutical companies will put together clinical trials to determine if the drug they are developing poses any risks to patients. According to the National Institute of Health, people in these trials voluntarily take a medication or use medical products to treat a condition. While the FDA does not have to approve these trials, there are review boards that do.
The FDA categorizes a clinical trial based on the following criteria:
- Phase 0: Involves limited human exposure
- Phase 1: Conducted with healthy volunteers to determine a drug’s most serious side effects
- Phase 2: Determines the efficacy of a drug among selected participants
- Phase 3: Experiments with different populations and dosages
- Phase 4: These are trials that take place after the FDA has approved the drug for marketing.
The results from clinical trials can vary from huge strides in medicine to failures that cause injury or illness to the volunteers.
The need for FDA oversight
Any Reno prescription drug lawyer knows that the FDA uses the results from clinical trials to approve a drug so it can be legally sold in the United States. A company can request a special protocol assessment from the FDA. This process enables the FDA to endorse a clinical trial, which can assure a manufacturer that positive results from the testing will likely mean a stamp of approval. Yet many companies skip this step. From Feb. 1, 2011, to Feb. 29, 2012, the FDA approved 35 drugs. According to a research letter in the Journal of the American Medical Association, only 28 of those manufacturers discussed their studies with the federal organization ahead of time.
The researchers who wrote the JAMA report believe that a mandatory FDA review process would help to quickly identify harmful and ineffective drugs. It could also expedite the approval of drugs that effectively and safely treat medical conditions.
The drug development process is complicated, but the oversight from various entities – including the federal government – is key to ensuring patient safety. Anyone with questions about clinical trials should consult with a Reno prescription drug lawyer.