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Morning Briefing

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Thursday, Mar 31 2022

Full Issue

Insulin Cost-Capping Bill Goes To House Floor Today

Also, the Washington Post reports on the death of Arthur D. Riggs, a medical researcher whose recombinant DNA experiments helped develop synthetic insulin. Meanwhile, a Food and Drug Administration panel concluded an experimental ALS drug from Amylyx hadn't proved effective.

The House is expected to vote Thursday on legislation aimed at capping the price of insulin, Majority Leader Steny Hoyer (D-Md.) announced. Hoyer told reporters on Wednesday that it鈥檚 鈥渋nexcusable鈥 people are being charged exorbitant聽prices for 鈥渁 life-saving and life-sustaining drug whose costs聽[have]聽not increased and whose research costs have been amortized a very long period of time ago.鈥 (Marcos, 3/30)

A measure intended to bring down the cost of insulin for people with diabetes is headed to the U.S. House floor for a vote Thursday. U.S. Rep. Lucy McBath, D-Marietta, is one of the primary sponsors of the House legislation, and Georgia Democratic U.S. Sen. Raphael Warnock helped reignite the conversation after President Joe Biden鈥檚 social spending and climate change legislation, known as Build Back Better, faltered. The insulin cost controls were in that package that stalled due to opposition from Senate Republicans and two moderate Democrats. Warnock is among several lawmakers who introduced stand-alone legislation to cap insulin at $35 a month for most patients. (Mitchell, 3/30)

In related news 鈥

Arthur D. Riggs, a medical researcher whose experiments with recombinant DNA led to the development of synthetic insulin for diabetes patients and helped launch the biotechnology industry, died March 23 at a hospital in Duarte, Calif. He was 82. His death was announced by the City of Hope, a medical center and research institute in Duarte with which Dr. Riggs was affiliated for more than 50 years. The cause was lymphoma. (Schudel, 3/30)

In updates from the FDA 鈥

By a narrow margin, an independent panel of advisers to the Food and Drug Administration on Wednesday decided that data from a single trial of an experimental drug developed by Amylyx Pharmaceuticals were not sufficient to conclude the therapy was an effective treatment against ALS. The vote was 6-4 鈥 closer than many expected given the FDA鈥檚 previously stated position that data from a single clinical trial of the Amylyx drug, called AMX0035, showed only a modest benefit and 鈥渕ay not be sufficiently persuasive鈥 to support approval. (Feuerstein and Florko, 3/30)

An independent panel of neurologists that advises the US Food and Drug Administration voted 6 to 4 Wednesday against recommending the agency approve a Cambridge company鈥檚 experimental therapy for amyotrophic lateral sclerosis, also called Lou Gehrig鈥檚 disease. The drug, produced by Amylyx Pharmaceuticals, slowed progression of the disease by 25 percent and improved survival a median of 4.8 months compared with placebo, according the the company. In what many described a difficult decision, a narrow majority of panel members were not convinced that Amylyx鈥檚 small clinical trial, which involved 137 ALS patients, proved the drug鈥檚 effectiveness. (Cross, 3/30)

In other pharmaceutical industry news 鈥

In the wake of the first Alzheimer鈥檚 drug approval in nearly two decades, pharmaceutical companies have been reinvigorated in their effort to tackle the neurodegenerative disease. But as Aduhelm takes its first stuttering steps on the market, it鈥檚 clear pharma鈥檚 struggles are far from over 鈥 leaving an opening for a crop of software and device companies to take aim. 鈥淭here鈥檚 been a big spike in investment in digital therapeutics that are targeting Alzheimer鈥檚,鈥 said Martin Culjat, a digital medicine consultant at Eversana who advises multiple companies developing the non-pharmacological therapies. 鈥淎 lot of that has been driven by the challenges in getting these drugs approved.鈥 (Palmer, 3/31)

Over the next few weeks, several major pharmaceutical companies will face a fresh crop of shareholder proposals that would require them to take steps to widen access to their medicines, an issue that is drawing increasing attention from investors. The proposals address such topics as making Covid-19 medical products more accessible, aligning lobbying with public policy goals for promoting greater affordability, and reigning in anticompetitive practices. Another proposal would require feasibility studies for transferring technology and know-how that could be used by generic manufacturers to make needed products for low-income countries. (Silverman, 3/30)

Joaquin Duato, the new CEO of Johnson & Johnson, is comfortable enough in his new position at the 135-year-old company to issue a bold claim just a few months into the job and during his first interview: he predicts the next decade will see more health-care transformation than occurred during the past century. Duato, the first non-U.S. born CEO for the company, and first to hold dual citizenship (Spain and U.S.), has been with J&J for three decades and was at one point the chief information officer of its pharmaceuticals business, giving him key insights into the role of technology in health care. (Rosenbaum, 3/30)

KHN: Despite Doctors鈥 Concerns, Pharmacists Get More Leeway To Offer Treatment With Testing

When Reyna or Justin Ansley or one of their three kids feels sick and needs to be tested for strep throat or flu, there鈥檚 a good chance they鈥檒l head to their local pharmacy in Hemingford or Alliance, Nebraska. Dave Randolph, the proprietor of both locations of Dave鈥檚 Pharmacy, can do a rapid test, give them medicine if they need it, and send them on their way. 鈥淚鈥檓 a cattle rancher,鈥 said Reyna Ansley, whose family lives about 15 miles outside Hemingford. 鈥淵ou don鈥檛 necessarily have the time to drive to the doctor and sit in the waiting room. It鈥檚 really quicker through Dave.鈥 (Andrews, 3/31)

On the opioid crisis 鈥

On the eve of a trial, the state of Florida has reached a settlement with a major pharmacy chain and two drug manufacturers over their roles in fomenting the opioid crisis that has gripped the United States for more than two decades. CVS Health will pay $484 million, and Allergan 鈥攁 unit of AbbVie 鈥 agreed to pay $134 million to settle a lawsuit filed by the state. In addition, Teva Pharmaceuticals will pay $195 million, and also provide $84 million worth of its generic version of Narcan, a nasal spray that is used to treat opioid overdoses in emergencies. (Silverman, 3/30)

West Virginia will receive $26 million in a settlement with the opioid maker Endo Health Solutions for the company鈥檚 role in perpetuating the state鈥檚 drug epidemic, the attorney general鈥檚 office said Wednesday. The announcement comes less than a week before the state is set to go to trial on Monday against three opioid manufacturers: Janssen Pharmaceuticals Inc., Teva Pharmaceuticals Inc. and Allergan. (Willingham, 3/30)

This is part of the Morning Briefing, a summary of health policy coverage from major news organizations. Sign up for an email subscription.
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