Controversial changes coming to FDA
The 21st Century Cures Act, which overwhelmingly passed the House last week, opens new avenues for companies to win quicker Food and Drug Administration approval. It continues to draw fire from safety advocates and worried payers, who foot the bill for expensive new therapies and may suffer if drugs aren’t thoroughly evaluated.
Pharmaceutical Research and Manufacturers of America, the nation’s major drug lobby, hailed the legislation for “enhancing the FDA’s ability to adapt to cutting-edge technologies utilized by America’s biopharmaceutical companies to bring new medicines to patients and their healthcare professionals,” the trade group said in a statement.
Dr. Michael Carome, director of Public Citizen’s Health Research Group, said the Cures legislation poses risks. “What this will do is it will hasten to market drugs and devices where there is not adequate evidence that they are safe and effective for their approved uses, and that’s not good for patients,” he said.
The bill allows for smaller clinical trials for new drugs that treat drug-resistant infections and will give speedier reviews to new devices given “breakthrough” status by the agency. It also raises the population cap to 8,000 patients from 4,000 on the humanitarian device exemption, which allows the sale of devices that have not been demonstrated as effective in treating the targeted disease.
The policy improvements would help strengthen the “innovation ecosystem” and support device development, said Scott Whitaker, CEO of the Advanced Medical Technology Association, the device industry trade group.
The FDA would also be required to give more weight to patient-experience data and consider real-world evidence or data in making approval decisions or evaluating studies required after approval. These changes “substantially undermine the process for approval of drugs,” Carome said.