The preelection legislative rush

Sep 04, 2024

Driving the Day

Fall colors hang from a tree as tourists walk past the U.S. Capitol building

As the fall approaches, Congress faces a slew of health care-related legislation that demands action. | Mark Wilson/Getty Images

AUGUST SLIPPED AWAY — The first of two busy periods in Washington this fall is upon us, with several pharma policy action items on the docket for the next few months. Here’s a quick look at the biggest issues awaiting Congress’ return next week:

Priority review vouchers: Reauthorizing the priority review voucher program for rare pediatric diseases is the most time-sensitive item, with its mandate lapsing at the end of the month.

The program aims to expedite drug development for those diseases by granting vouchers for expedited regulatory review to drugmakers that win approval for rare pediatric disease products. Companies can redeem them later for a different product or — if they don’t use them — sell them to other manufacturers.

The House Energy and Commerce Committee was scheduled to mark up a bill to re-up the program in June, but the meeting was canceled over an unrelated disagreement concerning privacy legislation. The Health Subcommittee approved the measure on a party-line vote in May after it was wrapped into separate legislation to expand children’s access to cancer drug trials.

Committee Chair Cathy McMorris Rodgers (R-Wash.) has said reauthorization of the program is a high priority, making it likely she’ll continue pushing for it before she retires at the end of this Congress. And the White House has included the program on its so-called anomalies list of expiring programs it wants lawmakers to extend alongside an appropriations package, an industry lobbyist granted anonymity to share sensitive information told Prescription Pulse.

BIOSECURE Act: House leadership placed the legislation, which would effectively ban Chinese biotech firms from doing business in the U.S., on the suspension calendar for when the chamber returns next week. That means it can’t be amended on the floor and needs a two-thirds majority vote to pass.

Industry analysts tracking the bill expect it to pass this year, likely alongside the annual defense authorization package.

FDA funding: Agency appropriations run out on Oct. 1, and the prospects of lawmakers advancing a standalone Agriculture-FDA spending measure before then are nil.

A continuing resolution would hold agency activities not funded by user fees at fiscal 2024 levels. The White House’s funding anomalies list doesn’t include any extra money for agency programs.

PBM oversight: The consensus we’ve heard from industry sources tracking various legislative efforts targeting pharmacy benefit managers is that their best chance at getting through Congress in some form is on a catchall spending package. Those measures include the House-passed bill tackling both hospital and PBM transparency and a Senate Finance-backed bill aimed at increasing PBM oversight within Medicare.

If lawmakers punt an omnibus until sometime before Christmas as expected, that’ll give proponents an opening for one last push before a new Congress takes over in January.

IT’S WEDNESDAY. WELCOME BACK TO PRESCRIPTION PULSE. Are you back in town after the August lull? Let your morning hosts know so we can grab coffee together!

Reach out and send tips to David Lim (dlim@politico.com or @davidalim) and Lauren Gardner (lgardner@politico.com or @Gardner_LM).

Eye on the FDA

Formaldehyde jar.

Some Democratic lawmakers are concerned about the delay of the FDA's proposal to ban formaldehyde in certain hair products. | burlesonmatthew/Pixabay | burlesonmatthew/Pixabay

FORMALDEHYDE RULE MIA — Another action item we’re awaiting is the FDA’s proposed rule to ban formaldehyde and formaldehyde-emitting chemicals as ingredients in hair-straightening products.

Democratic Reps. Nydia M. Velázquez of New York, Ayanna Pressley of Massachusetts and Shontel Brown of Ohio wrote to FDA Commissioner Robert Califf last week requesting an update on the proposal, which was previously expected in the spring. The Biden administration’s unified regulatory agenda for spring pushed back its anticipated release date to September.

FDA spokesperson Courtney Rhodes said the agency can’t comment on exact timing for the proposal but called it “a high priority.”

As part of the rulemaking process, Rhodes said, the FDA has conducted “an extensive risk assessment” on the chemical as a cosmetic ingredient in hair products, noting that scientific literature shows a link between formaldehyde in those items and increased cancer risk.

Why it matters: The lawmakers argue that women of color are disproportionately at risk because they’re more likely to provide and receive chemical hair relaxers such as keratin treatments and Brazilian blowouts.

Principal Deputy Commissioner Namandjé Bumpus announced the effort last fall when she was serving as the agency’s chief scientist.

“A major goal of mine is — and always really has been — to consider diverse cultural needs in the development and marketing of FDA-regulated products, including cosmetics,” said Bumpus, who is Black.

NOVAVAX SHOT AUTHORIZED — The FDA has authorized an updated version of Novavax’s protein-based Covid-19 vaccine, POLITICO’s Dan Goldberg writes.

The endorsement came Friday, a week after the agency green-lighted revamped formulations of two messenger RNA Covid vaccines ahead of the respiratory virus season.

In Congress

TOBACCO, FOODS PROGRAM GET HILL SPOTLIGHT — Two senior FDA officials will testify before a House Energy and Commerce subcommittee next week about regulatory programs that have garnered critical lawmaker attention: foods and tobacco.

Jim Jones, deputy commissioner for Human Foods, and Brian King, director of the Center for Tobacco Products, will appear before the health panel Tuesday to discuss their work and several bills before the committee, including legislation to expand the universe of tobacco products subject to user fees.

Members of both parties have criticized the agency’s oversight of vape products, arguing that it’s not doing enough to stop illegal imports of devices made in China that appeal to children.

“From the infant formula shortage, to lead poisoning in applesauce, to an onslaught of illegal Chinese vapes, Americans — and particularly children and teenagers — are at risk of consuming dangerous products, especially without safer alternatives and clear rules in place,” Rodgers and Rep. Brett Guthrie (R-Ky.), chair of the Health Subcommittee, said in a statement.

Despite that: Sixteen Democratic lawmakers filed an amicus brief with the Supreme Court on Tuesday in support of the FDA’s appeal of a 5th Circuit decision that struck down certain e-cigarette application denials.

Pharma in the States

CALIFORNIA PBM BILL PASSES — California legislators have sent a bill to Gov. Gavin Newsom’s desk that would create the first major regulatory program for pharmacy benefit manager practices in the state, POLITICO’s Rachel Bluth reports.

The measure would bring California in line with how other states regulate the industry, although it was changed throughout the year to drop some of its most controversial provisions.

Should Newsom sign the bill into law, it would require PBMs to be licensed by the state and pass along any discounts they negotiate with drug companies to a health plan instead of keeping a portion as payment. It also would prohibit PBMs from steering patients toward pharmacies they own.

Pharma Moves

Matt Schroeder is now Rite Aid’s chief executive officer as the company emerges from bankruptcy reorganization. Schroeder was most recently Rite Aid’s chief financial officer and succeeds Jeffrey S. Stein.

WHAT WE'RE READING

Bavarian Nordic CEO Paul Chaplin defended the price of the company’s mpox vaccine Tuesday, arguing the company needs the money to survive, POLITICO’s Carmen Paun reports.

A new study from the Bureau of Economic Analysis found that consumer out-of-pocket drug expenses have grown much more rapidly than negotiated drug prices since 2016, highlighting the role rebates play in price growth.

A multiple sclerosis pill achieved positive results in one Phase III trial but failed two others. Drugmaker Sanofi plans to apply for FDA approval to treat one type of the disease, Fierce Biotech’s James Waldron writes.

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