The Pharmaceutical Research and Manufacturers of America is uneasy about state laws which permit patient access to medications which the FDA has not approved. Colorado enacted a “right to try” law in May that allows patients and pharmaceutical companies to coordinate care, and NBC reports that other states are contemplating similar legislation.
PhRMA tells BioCentury that it has “serious concerns” about such measures because clinical trials are essential for determining a drug’s safety. The lobbying group also said such laws are “unlikely to add any meaningful new approaches that can optimize the federal expanded access programs,” referring to the FDA’s expanded access program, which is also known as “compassionate use.”
The FDA program has the same goal—to give patients with serious or immediately life-threatening diseases access to untested, unapproved medication. The FDA plays middleman in this scenario, and approves or rejects requests on an individual basis.
