In 2016, the U.S. Department of Health and Human Services issued a final rule that clarifies and increases the regulatory requirements and measures for submitting registration and summary findings of clinical trials at ClinicalTrials.gov, in accordance with Food and Drug Administration Amendments Act (FDAAA) 801. The final rule requires that sponsors, investigators, and all others involved in clinical trials, which trials must be presented, when they must be presented, and whether compliance has been accomplished. For instance, the final rule clarifies the meaning of which clinical trials are included in this Act. The final rule also expands the FDAAA 801 requirements by requiring the submission of clinical trial results information for trials of unapproved products. The regulation is effective after January 18, 2017 and responsible companies are expected to be in compliance by April 18, 2017.
In general, FDAAA 801 also mandates registration and reporting of summary results of clinical trials of medicines and devices subject to FDA regulation on the freely-accessible site ClinicalTrials.gov, no later than 12 months after the Completion Date. Prior to the FDAAA ruling, companies were able to hide finding of clinical trials if the results were negative or otherwise potentially damaging to drug marketing and sales.
President George W. Bush signed the Food and Drug Administration Amendments Act of 2007 (FDAAA), in 2007. This law reviewed, expanded, and reaffirmed several existing pieces of legislation regulating the FDA. These changes allow the FDA to perform more comprehensive reviews of potential new drugs and devices.
President Barack Obama signed an 11th hour 21st Century Cures act (Cures Act) at the end of 2016 which speeds up and by default weakens the drug review process by relying more heavily on surrogate endpoints and biomarkers instead of long-term outcomes trials with hard endpoints. Its okat to spread this logic to some biomarkers that gave been studied extensively, such as LDL, serum glucose, and hemoglobin A1c, they have been correlated with clinical endpoints in innumerable studies, but most biomarkers don’t have the scientific data backing them like these four do.
Rather than elicit the opinions in independent top scientists, the 21st Century Cures Act had the input of over 1,455 lobbyists and was also one of the most heavily lobbied bills in the 114th Congress. It included input from at least 78 pharmaceutical manufacturers, 24 device manufacturers, and 26 biotech companies. The Pharmaceutical Researchers and Manufacturers of America (PhRMA), the trade group representing the pharmaceutical manufacturers industry, spent $24.7 million of its overall $30.3 million on lobbying for the act, which clearly shows their interest in the Act.
This bill decreases the time it takes for drugs to get to market by reducing clinical trial requirements and weakens the safety and efficacy of both drugs and medical devices.