FDA Possibly Given More Power
The U.S. House of Representatives voted on Wednesday to give the Federal Drug Administration more power over drugmakers. This effort is to make it easier for the FDA to protect the public from dangerous drugs and medicines. The House passed the bill with a vote of 403-16.
The bill must be combined with a different version of the measure which was approved by the Senate in May before it can be signed into law by the President. Lawmakers are planning to merge the versions from the Senate and the House before the current fees expire in September.
This measure would let the FDA require post-approval studies of new prescription drugs and call for additional warnings for the labels of these drugs. Any company that does not adhere to the FDA directions could receive fines up to $50 million. If a company uses false or misleading advertisements they could face fines of $250,000.
These new provisions are meant to help improve the FDA’s oversight of drug safety, increase precision of the companies’ studies and clinical trials, and raise fees that the manufacturers pay to make reviews of medicines come out faster. Recently, the FDA has been criticized for not responding to adverse side effects of drugs quickly enough.
Drug companies are supporting the bill because they want to extend fees they pay to the FDA since this will help shorten the time it takes to complete product reviews.