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HHS Leaves Vacant More Than Half the Slots on a Key Vaccine Advisory Panel

STAT News reported:

A critical government advisory committee charged with charting U.S. vaccination policy appears to be atrophying, jeopardizing timely decision-making on how vaccines should be used in this country.

The Advisory Committee on Immunization Practices, which has in recent years been a 15-person panel, has eight vacancies — one of which dates back more than a year. The other seven members’ terms ended in July, though they were extended through the year because they had no replacements. There is no chairperson.

Four of the seven remaining members are due to finish their terms at the end of June, a cumulative exodus of expertise that will create what followers of the ACIP’s work believe is an unprecedented level of inexperience on the committee. Historically, three or four new members have been appointed to four-year terms every July, ensuring the roster always includes a mix of seasoned and new members.

Vaccine Makers Seek a Role in the Fight Against Antibiotic Resistance

CIDRAP reported:

In the offices of a biotech incubator hub just off University Avenue in St. Paul, Minnesota, the seeds of a vaccine that could prevent a common bacterial infection that affects millions of women and reduce infant deaths in low-resource countries are being carefully tended.

That’s where Syntiron Managing Director Lisa Herron-Olson, Ph.D., and her colleagues are working on developing a vaccine that targets the iron receptor proteins of Escherichia coli and Klebsiella pneumoniae, two bacterial pathogens that cause most urinary tract infections (UTIs).

The vaccine is designed to induce immunity by teaching the immune system to rapidly recognize proteins, such as the iron receptors, that all strains of E coli and K pneumoniae need to survive.

UTIs affect more than 150 million people — predominantly women — annually and are a primary driver of antibiotic prescribing worldwide. And for the estimated 25% to 30% of women who get repeated UTIs, that can mean several weeks, if not months, on antibiotics.

DEA Reverses Decision Stripping Drug Distributor of Licenses for Fueling Opioid Crisis

Associated Press reported:

The U.S. Drug Enforcement Administration is allowing one of the nation’s largest wholesale drug distributors to stay in business, reversing an earlier order stripping the company of its licenses for its failure to properly monitor the shipment of tens of millions of addictive painkillers blamed for fueling the opioid crisis.

As part of the settlement announced Wednesday, Morris & Dickson Co. agreed to admit wrongdoing, comply with heightened reporting requirements and surrender one of its two certificates of registration with the DEA. The Shreveport, La.-based company, which has around 600 employees and generates about $4 billion a year in revenue, also agreed to forfeit $19 million.

Last May, DEA Administrator Anne Milgram revoked both of Morris & Dickson’s licenses after an investigation by The Associated Press found the nation’s fourth-largest drug distributor kept shipping drugs for nearly four years after a federal judge recommended the harshest penalty for its “cavalier disregard” of rules aimed at preventing opioid abuse.

The DEA, in a news release, did not say why it disavowed its earlier order that Morris & Dickson cease operations. However, it once again faulted the company for turning a blind eye to thousands of unusually large orders for hydrocodone and oxycodone.

In a Showy Hearing, Bernie Sanders Gets Few Answers About Lower Drug Prices

STAT News reported:

The hearing, featuring Merck CEO Robert Davis, Johnson and Johnson CEO Joaquin Duato, and Bristol Myers Squibb CEO Chris Boerner, was designed to draw public interest, and in that respect, it worked. The wood-paneled hearing room in a Senate office building was standing room only, with an overflow room prepared. Photographers flocked for photos as Sanders shook hands with each executive, standard practice before such hearings begin.

Sanders’ staff got an arm workout switching out foam boards behind the chairman’s head, illustrating how the drug companies called to testify make more revenue from the United States on certain medications than the rest of the world combined.

But the production was thin on new ideas about how to help patients pay less for prescription drugs, and Sanders’ efforts to goad the CEOs into lowering their drug prices or freezing their salaries didn’t work. “Will you commit today at Bristol Myers Squibb to reduce the list price of Eliquis in the United States to the price that you charge in Canada, where you make a profit?” Sanders asked Boerner.

“Senator, we can’t make that commitment primarily because the prices in these two countries have very different systems,” Boerner replied.

The hearing is the latest in a series of CEO showdowns from Sanders, who previously called the head of Moderna to testify about vaccine prices, and the CEOs of insulin manufacturers to speak about their pricing practices.

New Report Highlights Weak FDA Oversight of Foreign Firms Making Medications for U.S. Market

CIDRAP reported:

The U.S. Food and Drug Administration (FDA) continues to struggle in overseeing more than 4,800 foreign drug manufacturers supplying medications for the U.S. market, although it has taken action to improve its drug-safety oversight, the Government Accountability Office (GAO) told the House of Representatives’ Subcommittee on Oversight and Investigations yesterday.

“We have identified long-standing weaknesses in FDA’s ability to oversee this manufacturing, an issue highlighted in our High-Risk Series since 2009,” Mary Denigen-Macauley, Ph.D., director of GAO’s healthcare team, testified.

As of 2022, 58% of makers of drugs bound for the US market were located overseas, the GAO noted.

In 2019, the FDA performed a record number of inspections of manufacturers in India and China, but the agency postponed most inspections after the COVID-19 pandemic began in 2020, according to the GAO. During this period, the FDA relied on remote inspections, document reviews, and reports from foreign regulators. But by 2022, a backlog had grown of manufacturers never inspected or not inspected within 5 years.

U.S. FDA Puts Hold on Gilead’s Blood Cancer Therapy Trials

Reuters reported:

Gilead Sciences (GILD.O) said on Wednesday the U.S. Food and Drug Administration had put a hold on trials testing the company’s blood cancer drug following increased risk of patient death in some studies.

The company will stop testing the drug, magrolimab, for all blood cancers and will review its safety across other studies such as those in patients with colon and breast cancers.

Gilead gained access to the drug through its $4.9 billion purchase of Forty Seven Inc in 2020.