More Than A Seat At The Table

By Ben Comer, Chief Editor, Life Science Leader

In an effort to include a diversity of viewpoints and positions about how biopharmaceutical companies operate, or should operate, this month’s cover story spotlights advocacy work conducted by the Initiative for Medicines, Access, and Knowledge, or I-MAK, as described by the nonprofit’s two cofounders and co-executive directors. For more than 15 years, Priti Krishtel and Tahir Amin have worked to improve access to affordable medicines all over the world by successfully challenging what they describe as patent system abuses. In the U.S., I-MAK’s overall priority is to bring members of the public, including patients, patient advocacy groups, and other stakeholders, into USPTO policy meetings and patent challenges, where their voices can join with the biopharmaceutical industry voices that never miss such meetings. At a time when American society is sharply divided, I-MAK aims to create shared spaces where people with different beliefs can disagree, productively if possible.

I was reminded of I-MAK’s concept of “participatory changemaking” during a panel on the Inflation Reduction Act at the Financial Times U.S. Pharma and Biotech Summit in New York City in May. The panel included Randy Burkholder, VP, policy, PhRMA; Lukasz Jarzyna, VP, head of global value, access, and pricing, Alexion; and Merith Basey, executive director at Patients for Affordable Drugs, an organization founded by multiple myeloma patient David Mitchell. Burkholder emphasized the substantial damage he expects the IRA to cause among biopharma companies, and Jarzyna made a case for keeping orphan drugs exempt from Medicare price negotiations, even if they have more than one indication, as long as a drug’s addressable audience doesn’t exceed the established orphan threshold of 200,000 patients. As the lone defender of the IRA’s price negotiation provisions, Basey spoke about the law’s ability to help ensure access to treatment; for example, shingles vaccines are now available for free for seniors in Medicare, and insulin copays have been capped. Basey was left shaking her head, however, when Burkholder and Jarzyna spoke in opposition to the law, and they shook their heads when it was Basey’s turn to speak. In other words, the panelists largely spoke past each other: protect drug revenue vs. protect patient access. Is there no middle ground to be found?

With I-MAK interviews fresh on my mind, I decided to find out what Burkholder would make of Amin’s suggestion that the IRA Medicare price negotiations — which can begin after nine years for small molecule drugs and after 13 years for biologics — were simply trying to accomplish what the Hatch-Waxman Act and the Biologics Price Competition and Innovation Act intended to do. Is it really so damaging to lower prices after similar periods of time, since generics and biosimilars were supposed to be available? Burkholder seemed to acknowledge the logic of the argument but suggested that a separate conversation on patents was needed and that his real problem with the IRA is related to its “meat-axe” approach to cutting prices. Basey was left shaking her head.