FDA Sued for Not Releasing Information About New Drug
As consumers, we want to be well informed about any medication that we may be prescribed or given when in a hospital. It is also vital that medical professionals have as much information about a drug prior to approving its use for their patients.
The Food and Drug Administration is the filter between drug manufacturers and medical professionals and their patients. We all must trust that the FDA exercises due diligence when reviewing and approving a drug for mass distribution. Should a defective or dangerous drug be permitted on the market, the health and well-being of the general public could be put at risk.
Recently, the FDA approved the use of two drugs used to treat Hepatitis C. The drugs are produced by a company called Gilead Sciences. But two advocacy groups are suing the FDA, claiming that the organization has thus far failed to release enough information about the drugs.
There have been two important concerns expressed about the drugs. First, a nonprofit group contends they are extremely expensive, so doctors and patients should have more information about their effectiveness prior to prescribing their use.
Secondly, as stated in the complaint, more data must be released in order for medical professionals to fully understand and study the efficacy and safety of the drugs. As of the writing of this post, neither Gilead Science nor the FDA had issued a response to requests for comments.
Certainly finding an effective way of treating a serious illness or condition is important. But it is important that the drugs being used are safe. It is critical that manufacturers are forthcoming about any potential dangers a drug may present to patients. In turn, doctors must carefully study the data available to determine if a drug is safe to prescribe.
If you are ever harmed by a dangerous drug because of a manufacturer's or physician's negligence, you may have the basis of for a lawsuit. A Texas defective and dangerous drugs attorney may be able to help you gain legal satisfaction.
Source: Reuters, "Health groups sue FDA for Gilead hepatitis C drug trial data," Jonathan Stempel, June 29, 2015