Imagine being told there’s a drug that might save your life — but your insurance won’t cover it for 18 months.
That’s the reality for patients under a new policy from Independence Blue Cross, a Philadelphia-based insurer. The insurer announced earlier this year that it will delay coverage of therapies that have received “accelerated approval” from the U.S. Food and Drug Administration.
Such delays can be fatal for people fighting for their lives. The Trump administration must beat back attacks on accelerated approval — and indeed, expand its use.
Accelerated approval was born out of necessity. During the HIV/AIDS crisis of the 1980s, patient advocates demanded faster access to promising therapies. In 1992, the FDA responded by creating the accelerated approval pathway .
The process allows the FDA to approve drugs based on how they affect surrogate endpoints — biological markers that indicate a drug’s potential benefit — while requiring manufacturers to conduct follow-up studies to confirm effectiveness. This balances speed with safety, allowing potentially life-saving therapies to reach patients three to five years sooner than through the traditional process.
More than 275 cutting-edge medicines received accelerated approval over its first 30 years. Nearly 65% of them target cancer; 42% address rare diseases. Many have provided hope where none existed before.
The breakthrough cancer drug Keytruda is a standout example. It first received accelerated approval in 2014 for treating a form of melanoma based on tumor response rates and durability of response. It has since received nearly 40 FDA approvals for treating all sorts of cancers.
Between 1992 and 2016, more than 76% of drugs approved through accelerated approval and available for at least five years went on to receive full FDA approval. Only 10% were withdrawn from the market, demonstrating that most of these treatments ultimately meet the highest regulatory standards while reaching patients years earlier than they otherwise would.
Some critics in recent years have seized on withdrawals like these as evidence that drug makers are abusing accelerated approval to get drugs on the market without sufficient evidence of clinical benefit. Aduhelm, an Alzheimer’s drug that received accelerated approval in 2021 and was later pulled from the market, is one particularly prominent target of their ire.
“The pendulum has shifted too far in the direction of approving drugs and biologics when there’s not good evidence of effectiveness and there hasn’t been adequate time to prove the therapies are actually safe,” said Robert Steinbrook, director of the left-leaning Public Citizen’s Health Research Group.
History just doesn’t warrant that kind of fear. Not only do most drugs that receive accelerated approval go on to receive full approval, the drugs approved via expedited pathways often offer greater clinical benefit than those cleared via the traditional process, according to research published in Health Affairs.
There are thousands of diseases without effective therapies of any kind. Accelerated approval represents the quickest way to get promising treatments to people desperate for them.
Fortunately, the Trump administration’s personnel choices signal support for faster drug approvals. The president’s pick for deputy secretary of Health and Human Services, Jim O’Neill, has long championed a modernized FDA. He has advocated for leveraging real-world data to assess drug effectiveness after approval — ensuring patients get treatments faster without sacrificing oversight.
Newly confirmed FDA commissioner Dr. Marty Makary has also expressed interest in streamlining regulatory processes in order to get “more cures and meaningful treatments for Americans.”
Accelerated approval is crucial to achieving that goal. The Trump administration must defend the pathway — and ensure that patients have access to the life-saving therapies it helps bring about.
Sally C. Pipes is President, CEO and Thomas W. Smith Fellow in Health Care Policy at the Pacific Research Institute.