Delivered every Tuesday and Friday by 12 p.m., Prescription Pulse examines the latest pharmaceutical news and policy.
| | | | |  | | By Lauren Gardner and David Lim | With Carmen Paun
| | |  Rep. Andy Biggs wants to expand the Right to Try program to incentivize more drugmakers to provide experimental treatments. | Drew Angerer/Getty Images | SPARSE USE OF RIGHT TO TRY — Former President Donald Trump has repeatedly touted his Right to Try law as a landmark achievement that equipped terminally ill patients with experimental treatments when no other alternatives exist. But the pathway was used for only four drugs last year — a total that critics of the program say demonstrates it was never needed in the first place. Rep. Andy Biggs (R-Ariz.), a proponent and co-sponsor of the 2018 law, said the program’s uptake is moving slower than he wants to see. The lawmaker wants Trump to expand the law in his first 100 days if he wins reelection — an idea the Trump campaign said the former president is open to. “We protect and give some immunities and benefits to pharmaceutical companies,” Biggs said. “We could have provided more of an incentive to pharmaceutical companies to provide these drugs and biologics to people who need them.” Patients have had access to a similar program for decades. The FDA’s expanded use pathway — often referred to as the compassionate use program — has enabled those with serious diseases and conditions to access investigational drugs when no comparable alternative therapy is available. In recent years, thousands of patients accessed experimental treatments under the compassionate use program — which typically includes an FDA review of the proposed use of a therapy. In fiscal 2023, the agency received 2,288 individual compassionate use requests for drugs and biologics, allowing 2,261 of those to proceed. Reopening a debate over access to experimental treatments could portend other changes to agency policy in a potential second Trump administration. The GOP’s 2024 platform calls for expanded access to new prescription drug options. “In his second term, President Trump will of course remain open to other pathways to expand 'Right to Try' to save more American lives,” Trump campaign spokesperson Karoline Leavitt said in an email. IT’S TUESDAY. WELCOME BACK TO PRESCRIPTION PULSE. Simone Biles and her mother, Nellie, have a new paid partnership with Eli Lilly promoting diabetes drug (and GLP-1) Mounjaro — though neither takes it. Send news and tips to David Lim (dlim@politico.com or @davidalim) and Lauren Gardner (lgardner@politico.com or @Gardner_LM).
| | |  Sen. J.D. Vance is the co-sponsor of the FAUCI Act, which would limit FDA, CDC and NIH senior officials' ability to serve on drugmakers' and device makers' boards. | J. Scott Applewhite/AP | A LOOK AT VANCE’S PHARMA INTERESTS — With GOP presidential nominee Donald Trump selecting Ohio Sen. J.D. Vance as his running mate, Lauren looked back on his last 18 months of congressional service to sift out pharma-related positions of note. Here are a few highlights: China and supply-chain concerns: Vance, a member of the Senate Special Committee on Aging, has signed onto letters to the FDA and HHS expressing concerns about U.S. supply chains for critical drugs like chemotherapies and personal protective equipment — and the country’s reliance on China for both. “Despite billions in federal spending and investment to build out discreet production lines within the medical equipment supply chain, projects remain incomplete. The programs established [by] the Trump administration now lie fallow under your watch,” Vance wrote in a February letter to HHS Secretary Xavier Becerra. “New initiatives have failed to bear fruit while China retains control of critical consumables markets.” Post-government board service: Vance co-sponsored a bill in May that would prevent senior officials from the FDA, the CDC and the NIH from serving on the boards of any drug or device companies within eight years of government service. The bill is dubbed the FAUCI Act, invoking former National Institute of Allergy and Infectious Diseases Director Anthony Fauci as a favorite foil for Republicans who became disillusioned with the government’s Covid-19 response. “This legislation will shut the revolving door between Big Pharma and federal agencies tasked with protecting the American people,” Vance said in a statement. “It would go a long way in restoring trust in our government.” POLITICO’s Ben Leonard and Dan Goldberg have a broader look at Vance’s health policy record.
| | | | Understand 2024’s big impacts with Pro’s extensive Campaign Races Dashboard, exclusive insights, and key coverage of federal- and state-level debates. Focus on policy. Learn more. | | | | | | | | CALIFORNIA DEFENDS OREGON TRANSPARENCY LAW — California Attorney General Rob Bonta led 20 other state and district lawyers in an amicus brief Monday supporting Oregon’s drug price transparency law. PhRMA, the brand-name drug lobby, challenged the 2018 law requiring drugmakers to report certain information when a product’s list price — before accounting for any discounts — increases by a certain percentage. A district court ruled partially in favor of the group, a decision the state appealed to the 9th Circuit. States “stand to benefit from laws like Oregon’s, using the information they make available to craft their own transparency laws and other prescription drug legislation,” Bonta wrote in the brief. “Through these laws, States can collect and analyze relevant data to inform solutions to contain the prices of drugs necessary to our residents’ health.” California has a transparency law similar to Oregon’s, and the states that joined the brief have passed their own reporting laws or created prescription drug affordability boards to try to lower drug costs for their residents. PhRMA has until Sept. 4 to file a response to Oregon’s case. The U.S. District Court in Oregon ruled that the law’s reporting requirements violated the First Amendment. It also ruled that it violated the Constitution’s takings clause prohibiting private property being taken for public use without just compensation since it authorizes the state to publish trade secrets if it believes they’re in the public interest.
| | | | CDRH REORG — Dr. Jeff Shuren, the FDA’s top medical device regulator, unveiled a number of changes to his center’s structure Monday, which he says will allow it to better meet user fee commitments and other priorities. The FDA medical device unit is creating a division of digital communications and marketing and raising its Office of Communication and Education to so-called super office status. It is also splitting the biostatistics division housed within its Office of Clinical Evidence and Analysis into three divisions. The Center for Devices and Radiological Health’s Office of Surgical and Infection Control Devices is also splitting its Division of Infection Control and Plastic Surgery Devices into two divisions: one focused on plastic and reconstructive surgery devices and the other on infection control devices.
| | | FDA TO REVAMP TOBACCO PORTAL — The FDA will launch a new online platform next year for companies to submit applications for new products, the agency said Monday. The changes are intended to funnel electronic submissions into one system for premarket tobacco product applications, substantial equivalence reports and amendments, among other documents, the FDA said.
| | | | VACCINATION WITH NEW MALARIA SHOT STARTS — An 8-month-old in Ivory Coast received the R21 malaria vaccine Monday, marking the start of a vaccination campaign across the country with the new shot. Authorities in Ivory Coast plan to vaccinate a quarter million children under 2 years old. Ghana, Nigeria, Burkina Faso and the Central African Republic have also licensed the shot and are preparing to administer it.
| | | | Understand 2024’s big impacts with Pro’s extensive Campaign Races Dashboard, exclusive insights, and key coverage of federal- and state-level debates. Focus on policy. Learn more. | | | | | | | | Andrew Zacher has joined Arnold & Porter as counsel in the firm’s FDA practice. He joins from Paul Hastings and was deputy chief of staff at the FDA. Public Citizen announced Lisa Gilbert has been elevated to co-president alongside current president Robert Weissman.
| | Vertex Pharmaceuticals is suing the federal government for permission to pay for fertility treatments for patients taking its sickle cell disease gene therapy, preparations for which can render people infertile, Bloomberg reports. | | | | Follow us on Twitter | | | | Follow us | | | | |
