Capsule: FDA Pick Hahn Gets His Turn in the Senate Spotlight

Welcome to Capsule, where we’ll give you your weekly dose of what to watch out for in the health-care space. Each week our reporters Ayanna Alexander and Jacquie Lee get you prepped for the week’s hottest health-care topics.

Jacquie: Dr. Stephen Hahn is facing the hot seat this week. His confirmation hearing for commissioner of the Food and Drug Administration is set for Wednesday. Lawmakers have told our colleague Alex Ruoff we should expect questions about drug pricing, drug shortages, and e-cigarettes. But we also poked around to see what drug wonks want to know.

Academics and lawyers have quite a few pressing questions. One comes from Inmaculada Hernandez from the University of Pittsburgh School of Pharmacy:
“Recently, there has been new evidence that drugs approved through the accelerated approval pathway are not effective. How will the FDA assure that all of those drugs are identified and removed from the market?”

Lately the FDA has spent more time touting the number of drugs it has approved rather than the quality of products it reviews. That “deviates from the original purpose of the agency, which is to prevent non effective and unsafe drugs from reaching the public,” she said.

Ayanna: Hahn, an oncologist, has medical experience, but how he would approach the FDA job is an open question.

“Although Dr. Hahn is obviously a well-known and established oncologist, he is a little bit of an unknown in FDA circles, especially in comparison to former Commissioner Gottlieb,” Chad Landmon, who chairs the FDA group at Axinn, Veltrop & Harkrider LLP, said.

“Given that addressing high drug costs is a top priority of [Health and Human Services] Secretary [Alex] Azar, the Trump administration, and Congress, it’s likely that Dr. Hahn will continue to promote FDA’s efforts in this area, including by promoting speedier approvals of generic drugs and biosimilars.”

Jacquie: Big questions remain as to whether the agency will (or can) do anything to help biosimilars—treatments similar to other biological products already approved by the FDA—succeed in the marketplace though. Former Commissioner Scott Gottlieb said last month the agency has done pretty much all it can by approving the drugs at a record-breaking pace.

Our colleague Jeannie Baumann has also heard regenerative medicine will probably come up in the hearing, particularly whether the agency plans on ramping up enforcement against clinics and companies selling unapproved stem cell therapies.

Ayanna: The medical device industry also agrees that Hahn’s background makes him a great fit for the position.

Sources tell me that they aren’t too sure what the commissioner nominee will do for cybersecurity within the pharma space, however, but hope that it remains a priority for the agency.

Jacquie: And because money rules the world, we should expect something about funding to come up. Steven Grossman from the pro-agency group Alliance for a Stronger FDA says he hopes Hahn will push for more funding for the agency.

Ayanna: Switching gears now to the privacy side of health care, which is typically managed by the HHS. Privacy around health data was a highlight last week when news broke about Google’s partnership with Ascension that could lead to identifiable health data from millions of patients falling into Google’s lap.

The HHS is now investigating Google for potential Health Insurance Portability and Accountability Act violations. That makes attorneys think changes to that law’s outdated U.S. health privacy rules could be just around the bend.

Sources tell me that this investigation shows the need for HIPAA reform because Google and Ascension could legally pull patient health data without consent. The current rules only cover health systems, clearinghouses, and insurance plans—plus, the business associates of those three.

All of this Google attention prompted Sens. Bill Cassidy (R-La.) and Jacky Rosen (D-Nev.) to introduce a bill Nov. 14 intended to prevent data mining of Americans’ personal health data from smartwatches and other personal wearables.

Why is this important to Congress? The tech giant also plans to buy Fitbit—a wearable tech manufacturer.

These personal devices aren’t covered under HIPAA, unless they’re produced or sold by a business associate—the way Google and Ascension are, and sources say that could get a little tricky under the current rules.

With the number of big tech and health-care partnerships steadily increasing, could the HHS Office for Civil Rights and lawmakers upgrade HIPAA before Congress goes home for the holidays?

That’s still unknown.

Just know, we’ll be watching for that as we head into 2020—an election year, which sources say will make any changes even harder to complete.

What Else We’re Watching

The next presidential debate is Nov. 20, so buckle up for another round of Medicare for All and how candidates plan on lowering health-care costs.

The Senate Finance Committee’s health subcommittee will be talking Alzheimer’s awareness, treatments, and care coordination on Wednesday.