The US Food and Drug Administration (FDA) is caught between Scylla and Charybdis, with competing pressures to speed drugs to market and to ensure they are safe and effective. On one side, patients, families, and advocates are clamoring for faster approval of new drugs that offer treatments for serious and life-threatening diseases. They believe that delay is potentially deadly. Drug companies concur, eager to push new drugs to market as quickly as possible to start generating revenue. On the other side, recalling experiences with thalidomide, rofecoxib, bevacizumab, and other ineffective or harmful drugs, physicians and watchdog groups worry about the safety, real-world efficacy, and financial waste inherent in the rapid approval of drugs that eventually prove to be unsafe or ineffective.
Identify all potential conflicts of interest that might be relevant to your comment.
Conflicts of interest comprise financial interests, activities, and relationships within the past 3 years including but not limited to employment, affiliation, grants or funding, consultancies, honoraria or payment, speaker's bureaus, stock ownership or options, expert testimony, royalties, donation of medical equipment, or patents planned, pending, or issued.
Err on the side of full disclosure.
If you have no conflicts of interest, check "No potential conflicts of interest" in the box below. The information will be posted with your response.
Not all submitted comments are published. Please see our commenting policy for details.
DiMagno SSP, Glickman A, Emanuel EJ. Accelerated Approval of Cancer Drugs—Righting the Ship of the US Food and Drug Administration. JAMA Intern Med. Published online May 28, 2019179(7):922–923. doi:10.1001/jamainternmed.2019.0584
Browse and subscribe to JAMA Network podcasts!
Customize your JAMA Network experience by selecting one or more topics from the list below.
Create a personal account or sign in to: