December 12, 2019
With this afternoon’s full U.S. Senate vote, Stephen Hahn, M.D. was confirmed as FDA Commissioner. Dr. Hahn’s leadership comes at a historic time.
We are amid a rapid period of medical innovation that holds the promise of delivering personalized treatments and curing diseases that, just a few short years ago, were death sentences. In order to continue to build on this important medical progress, Dr. Hahn and his team at the FDA will need to continue to ensure that Washington doesn’t stand in the way of patients accessing the care that they and their physicians believe will best meet their medical needs and personal preferences.
Here are some key areas that will move us closer to ensuring that the right patient has access to the right treatment at the right time:
Right to Try. The federal
Right to Try law, signed by President Trump in May 2018, is saving lives today.
What will you do to protect and expand the ability of patients to access promising
investigational treatments as they work their way through the years-long FDA
approval process?
Off-label communications.
Under current FDA policy, communicating about an approved treatment for a
legal, off-label use can result in criminal prosecution and penalties even
though using off-label treatments are an essential (and lawful) part of a
physician’s toolbox. As a physician, you understand the treatment needs of
patients but know that not all physicians have access to full information about
treatment options, especially when addressing with rare disease or aggressive
forms of cancer, due to these FDA-imposed gag rules. What will you do to ensure
that physicians and insurers have the most accurate, truthful information about
how off-label treatments are being used to treat patients?
Reciprocity. Some of the
world’s leading medical treatments are increasingly found in other countries. Do you believe that there should be a pathway for
harnessing the important scientific work that has already been undertaken
elsewhere on behalf of patients? And, if so, what approaches might you take to
achieve patients in the U.S. have the broadest access to the world’s most
innovative treatments?
Transparency. The FDA has
a long and well-documented history of obscuring the decision-making process it uses
to allow patients to access its Compassionate Use program. In fact, it seems to
routinely deny FOIA requests related to the Compassionate Use program.
Not only are there
years-long legal challenges involving these matters in federal court (including
one notable
one from the Goldwater Institute asking for the decision criteria used to
grant an Ebola treatment to U.S. aid workers who received medical evacuation
out of Liberia), but the FDA has staked out a position that is in stark
opposition to the Freedom of Information Act (FOIA). In particular, the FDA has
refused to answer As FDA Commissioner, what will you do to ensure that these life-or-death
decisions are not government secrets?
Medical autonomy. Decisions
about one’s medical treatments are among the most personal. When a patient’s
life hangs in the balance, who should hold the ultimate authority over the best
path forward: the patient under their doctor’s care or the federal government?
An FDA that embraces innovation is key to a healthcare future that works for patients, and we look forward to working with Dr. Hahn and patients across the country to make this a reality.
