What questions should Trump’s FDA nominee be answering?
Hahn Hearing
The November 20 confirmation hearing to decide whether Stephen Hahn, President Donald Trump’s nominee to head the Food and Drug Administration (FDA), should get the job comes at a time when the agency is being scrutinized as never before. Hahn, currently the chief medical executive of MD Anderson Cancer Center in Texas, is getting grilled by senators on topics ranging from the FDA’s role in developing new therapies to its ability to stop epidemics, such as opioids and vaping.
Nicholas Florko – with assistance from Damian Garde, Megan Thielking, Sharon Begley and Andrew Joseph – assembled a list of questions Hahn should be asked and published them in STAT. Here are some highlights.
How do you feel about Twitter?
Hahn’s predecessor, Scott Gottlieb, constantly used the social media platform to communicate with the public about his agency’s policy decisions and other matters. While it seems that Hahn has a locked account, it may be a habit he acquires if he becomes the FDA director.
Should the FDA regulate drug prices?
Some senators will be looking for a commitment on this issue. Gottlieb took issue with drug makers that kept lower-cost generics from coming to market. Hahn could be asked tactical questions on this issue.
How will you rein in the e-cigarette industry and curb vaping among teens?
Because of the outbreak of vaping-related illnesses and the surge in vaping among teenagers, the FDA has come under scrutiny about not getting involved sooner in the regulatory requirements for the industry. Public health advocates want the FDA to try to cut teen e-cigarette usage, while the vaping industry wants to be sure the products are available to adults.
How can the FDA tackle Alzheimer’s?
While Hahn has a personal connection to the disease, because his father died from it, drug makers have not developed drugs that could be submitted to the FDA for review. Hahn could try implementing policies to encourage drug makers to work closely with the FDA to advance Alzheimer’s therapies.
How much data does a new drug really need?
While the FDA has been willing to consider less data before approving new drugs recently, there are concerns about a balanced approach. In the words of the article, “A flexible FDA means a quicker path to profit, a cheaper drug-development process and thus a more appealing investment.” Will public health advocates be convinced that quicker approvals allow for adequate safety and efficacy testing?
Controversy seems to follow everywhere you go; what gives?
Hahn faced three controversies in previous positions: one involved doctors improperly planting radioactive seeds meant to treat prostate cancer into veterans, another almost got MD Anderson removed from the Medicare program and the third left Hahn assuring his colleagues he did not racially target scientists. He may use these occasions to demonstrate is ability to clean up messes and be a master of “institutional turnaround experiences.”
Is $1 million too much to charge for a gene therapy?
While cutting-edge gene therapies that cure devastating diseases may be worth the cost, some people describe them as price gouging. Anything Hahn says will convey his views on the debate over the rising costs of drugs.
Should the FDA stop approving new opioid medications?
Hahn may be asked whether the FDA should approve new opioids in the wake of the addiction crisis. So far, the agency has reviewed marketing applications for new drugs, including opioids, but it has developed draft guidelines to assess future opioid candidates that consider the public health consequences of new approvals.
In your experience as a physician-researcher, will taxpayer-funded science suffer if human fetal tissue procurement is barred?
While HHS has discontinued government-run research involving fetal tissue obtained from elective abortions, some scientists think fetal tissue research is essential to developing lifesaving vaccines and treatments. Where does Hahn stand?
What evidence of safety would you require in order to approve a CRISPR-based therapy?
The FDA has approved two gene therapies that introduce new DNA directly into patients, and more clinical trials are underway. CRISPR-based genome editing can alter DNA in ways that could raise the risk of cancer and other serious diseases, miss its target or scramble the genome in potentially harmful ways. To catch these problems, researchers can sequence the targeted genome. Although that may be time-consuming and expensive, the FDA may or may not require that procedure in preclinical studies.
Can clinical trials based on one person be enough?
Personalized medicine may mean creating drugs that may have consequences for a limited number of individuals. How can the FDA decide on a process could be too permissive or not permissive enough?
How should the FDA improve regulating rogue stem cell clinics?
Patients can be at risk from stem cell clinics that offer unproven, and sometimes unsafe, stem cell “therapies.” How can the FDA improve oversight of these clinics?
Only time will tell how Hahn performed. Only circumstances will show whether he is the right person for the job.