FDA Exploring Route To Cheaper Drugs Through Imports

Axios: FDA Mulls Drug Importation With States
The FDA has started discussions with states over creating a way to import drugs from Canada — a policy the Biden and Trump administrations both embraced to bring down health costs but which experts regard as having limited impact. With President Biden's drug pricing agenda stalled, importation could allow states to take advantage of lower drug prices abroad without the need for direct action to limit prices in the U.S. Under one pathway, states, wholesalers and pharmacies submit importation proposals to HHS, which would be subject to safety and cost conditions. (Bettelheim, 4/12)

And more FDA news —

Politico: Lawmakers Demand Answers From FDA After Investigation On Food Failures 
The chairs of two powerful committees in the House and Senate that oversee FDA are demanding answers in response to a POLITICO investigation into the agency’s failure to act on a slew of pressing food safety and nutrition issues. Sen. Patty Murray (D-Wa.), who leads the Senate Committee on Health, Education, Labor and Pensions, sent a strongly-worded letter to FDA Commissioner Robert Califf Monday afternoon seeking “immediate action to ensure the FDA is doing all it can to fulfill all aspects of its mission to protect the health and safety of the American people.” (Evich, 4/11)

Stat: FDA Scolds Bausch Health For Misleading Claims About A Psoriasis Cream
The U.S. Food and Drug Administration has scolded Bausch Health for a video and webpage that made misleading claims about a plaque psoriasis treatment, the second time this year the agency has tagged a big drugmaker for overlooking the risks and benefits of a medicine in promotional materials. In a March 22 letter, the FDA wrote that a Bausch video failed to say that its Duobrii topical cream can cause birth defects. The video, which had been visible on YouTube but has since been taken down, failed to note that women should get a pregnancy test before applying the cream and should use contraception. The video, which can still be seen here, also lacked warnings about photosensitivity and the risk of sunburn. (Silverman, 4/11)

In updates on insulin pricing —

Stat: New Bipartisan Insulin Policy Aims To Entice Drugmakers To Lower Prices
A bipartisan group of four key lawmakers unveiled a long-shot policy that aims to alleviate one of the American health care industry’s most embarrassing problems: mind-bogglingly high prices for insulin, a drug millions of Americans need to survive. The policy outline released Monday is a reboot of a three-year-old bill introduced by Sens. Jeanne Shaheen (D-N.H.) and Susan Collins (R-Maine). It would dangle a carrot for drugmakers to lower their list prices. Insurers and middlemen wouldn’t get to keep fees for diabetes drugs — but only if drugmakers lower list prices for drugs back to 2006 levels. It would also make sure patients with Medicare or private insurance don’t pay more than $35 per month for their insulin, though it would not offer the same protection to the uninsured. (Cohrs, 4/11)

Stat: Human Rights Watch Says Unaffordable U.S. Insulin Is A Human Rights Abuse
Insulin prices are sky high. High enough, now, that Human Rights Watch is declaring that insulin’s price tag contributes to human rights abuse. The international advocacy organization best known for investigating war crimes, genocides and dictatorships is out with a new report that argues that the human rights of people with diabetes are being violated when they’re unable to afford their insulin. That makes insulin makers, who set those high prices, complicit in human rights abuses, according to Matt McConnell, the lead author. “Drug companies’ drug pricing practices  … are contributing to human rights abuses,” he told STAT. (Florko, 4/12)

In other pharmaceutical industry news —

San Francisco Chronicle: Johnson & Johnson Must Pay $302 Million For Deceptive Marketing Of Pelvic Mesh Implants, Court Rules
Johnson & Johnson must pay $302 million in penalties to the state for many years of deceptive marketing to doctors and female patients about pelvic mesh implants that could cause serious vaginal pain and physical damage, a state appeals court ruled Monday. A San Diego County judge had assessed $344 million in penalties against Johnson & Johnson subsidiary Ethicon in January 2020, finding after a non-jury trial that the company had made misleading and potentially harmful statements in hundreds of thousands of advertisements and instructional brochures for nearly 20 years. The Fourth District Court of Appeal said $42 million of that amount, penalties for the company’s spoken sales pitches to doctors, was unjustified because the state had no evidence of what the sales representatives had actually said. (Egelko, 4/11)

AP: Efforts To Make Protective Medical Gear In US Falling Flat
When the coronavirus pandemic first hit the U.S., sales of window coverings at Halcyon Shades quickly went dark. So the suburban St. Louis business did what hundreds of other small manufacturers did: It pivoted to make protective supplies, with help from an $870,000 government grant. But things haven’t worked out as planned. The company quit making face shields because it wasn’t profitable. It still hasn’t sold a single N95 mask because of struggles to get equipment, materials and regulatory approval. (Lieb, 4/11)