Speaking to agency staffers last week, newly installed Secretary of Health and Human Services Robert F. Kennedy, Jr., insisted that "nothing is off limits" in his fight against chronic disease.
It's an encouraging message. HHS is in desperate need of modernization.
To see how HHS's inefficiency and sluggishness have undermined the health of Americans, look no further than the Food and Drug Administration, one of the regulatory agencies under the aegis of HHS. Among other things, the FDA is charged with evaluating the safety and effectiveness of new medicines.
Too often, however, the FDA shows little urgency in executing this task. Between 2011 and 2020, it took new drugs more than a decade, on average, to move from Phase I development to full regulatory approval.
One of the reasons for these lengthy delays is that the FDA's incentives often conflict with those of patients. After all, any mistake in the approval process would lead to a very public fallout for the agency.
The cost of moving slowly, however, is invisible — and borne largely by patients.
That cost can be significant. A 2015 study by Canadian oncologist David Stewart of 21 drugs approved between 2001 and 2015 found that every hour of regulatory delay cost North American patients 29 life-years. That's 1 year for every 2.2 minutes of delay.
Seen in this light, the FDA's default posture of caution isn't prudent or harmless. It can be deadly.
If given the option, many cancer patients would gladly take the risks associated with accepting an experimental therapy, if the alternative was certain death. But many never get a say in the matter.
One way Kennedy and President Donald Trump's nominee to head the agency, Dr. Marty Makary, can address this problem is by protecting access to — and expanding the use of — the accelerated approval program. This process allows the agency to evaluate a potential new medicine based on how it affects a "surrogate endpoint" — that is, a reliable indicator that predicts that a drug will be clinically effective.
In cancer, for example, a shrinking tumor may be a viable surrogate endpoint suggesting that a drug is effective.
By sidestepping the need for direct proof of clinical benefit — which may take years to manifest — accelerated approval allows new therapies to garner approval and reach patients more quickly.
By one estimate, accelerated approval reduces approval times from a mean of eight years to 4.8 years.
The insurance industry is not always a fan of novel medicines reaching patients faster. Insurers could face higher costs, as their beneficiaries understandably insist on having access to the latest and greatest drugs.
Just this month, the insurer Independence Blue Cross, based in Philadelphia, announced it would not cover drugs that have received accelerated approval for 18 months following approval.
And under the Biden administration, the Centers for Medicare and Medicaid Services erected bureaucratic barriers designed to limit Medicare beneficiaries' access to drugs that received accelerated approval.
Kennedy needs to make it clear that this kind of behavior — whether within CMS or the private insurance industry — won't be tolerated. The whole purpose of accelerated approval, after all, is to get medicines to patients, particularly those with life-threatening illnesses, faster.
RFK Jr. might not be a conventional choice for HHS Secretary. But the status quo has cost lives and money on an unacceptable scale. Kennedy should seize the opportunity to clear the bureaucratic obstacles that have made health care less efficient and more costly than it should be.
Sally C. Pipes is President, CEO, and Thomas W. Smith Fellow in Health Care Policy at the Pacific Research Institute. Her latest book is The World's Medicine Chest: How America Achieved Pharmaceutical Supremacy -- and How to Keep It (Encounter 2025). Follow her on X @sallypipes. Read Sally Pipes' Reports — More Here.