Often, a drug’s initial approval only hints at its full therapeutic potential and the eventual number of patients who may benefit over time. Continued R&D investment can unlock much more utility before the drug ultimately goes generic, but those investments require adequate incentives.

Thanks to the selfless efforts of a handful of smart and dedicated volunteers from a few tech transfer offices (TTOs), law firms, and investment firms, the fraught process by which technology licenses are extricated from universities is getting a significant upgrade.

The recent announcement by Alnylam Pharmaceuticals that it was holding off on a planned Phase 3 pivotal study for vutrisiran (marketed as Amvuttra in its sole approved indication so far, hATTR amyloidosis with polyneuropathy) in Stargardt disease illustrates how the Inflation Reduction Act is already having a negative impact on small molecule and orphan drug R&D prioritization. Alnylam’s announcement also brought out skeptics of the biotech industry, who argue the new law is being scapegoated by innovators who want to overturn its Medicare drug-negotiation provisions.

As the founder of two biotech companies in Arizona that are currently fundraising to support drug development, it’s clear to me that the Inflation Reduction Act will steer me away from developing cancer drugs for older Americans. This is a problem that can be fixed.

Over the past four decades, David Beier has observed and participated in the evolution of the US biotechnology industry for several key vantage points. The industry’s success and freedom to innovate, he says, has been underpinned by – and helped create – a marketplace that was open enough to fully reward risk-taking investors devoting capital to cutting edge science. Today, that success faces new threats.

A conversation with former Pfizer research head John LaMattina about the persistence of the misperception that NIH invents the drugs that biopharma companies sell, the chance encounters that can lead to breakthroughs years or even decades later, and the tough math facing investors and heads of research across the industry when deciding whether to invest in a project that’ll only enjoy nine years of market exclusivity.

We talk a lot about access to care and the hurdles that might keep people from getting the medicine they need. Usually, we’re talking about the price of healthcare or the inanity of insurance requirements. But other hurdles hide in plain sight, as is the case with naloxone (Narcan), birth control, and other drugs that could (and should) be available over-the-counter (OTC). 

If the FTC begins to look askance at M&A between commercial-stage biopharmaceutical companies and the innovative smaller biotechs that so often are the sources of new medicines, that would be bad news for future R&D and the patients who depend on our industry for life-saving medicines. That they might do so in the name of preserving or protecting innovation in the first place would add insult to injury.

Often, a drug’s initial approval only hints at its full therapeutic potential and the eventual number of patients who may benefit over time. Continued R&D investment can unlock much more utility before the drug ultimately goes generic, but those investments require adequate incentives.

We are deeply concerned the new Senate drug bill fails to deliver adequate relief to the nation’s seniors and their families. It falls short of a generational opportunity to meaningfully lower Medicare beneficiary and taxpayer out-of-pocket costs. The revised language is not good enough for patients, bad for biopharma innovation, and provides no guarantee that PBMs and insurance plans will share savings with beneficiaries.

As the 2022 midterms loom, drug pricing reform is again at the forefront of the conversation. And with inflation at 8.6%, it’s undeniable – Americans are hurting, and paying less at the pharmacy counter may alleviate part of that burden. But not all drug pricing reforms are created equal. So how would price controls impact R&D?