(Large) writing on the wall for drug info

A seemingly uncontroversial FDA proposal to provide patients with printed one-pagers of drug information has prompted an impassioned online petition for potentially more printed information and seemingly, more paper.

No, this isn't a Dunder Mifflin campaign. The effort is led by the Pharmaceutical Printed Literature Association and has garnered nearly 50,000 signatures, thousands of them from individuals across the country (h/t Nick Florko for the find). The association is arguing for minimum font sizes, clear headers, and different colors to provide "scientifically proven clarity." The changes would be especially important for seniors and other patients without easy digital access to drug information, they write.

The FDA first proposed the regulation in late May. Comments are due by next Monday.

PPLA President Dave Joesten told D.C.D. that it's worked to ensure people impacted by the rule, such as "seniors, patients in rural communities, lower-income Americans and pharmacists – know that they can contact the FDA themselves to make sure their voices are heard."

FDA POLICY

Slow eye drop recall stirs lawmakers

It took nearly three weeks for the maker of eye drops to recall its products after an FDA request, once again highlighting the agency's limited power in recall issues. While there were no reports of injuries, some lawmakers are arguing that this is the latest example of why the agency should be given the power to force them, John Wilkerson writes.

It started when FDA inspectors found unsanitary conditions at a facility in India that makes over-the-counter eye drop products that multiple U.S. retailers and distributors sell under their own brand names. The FDA first asked the manufacturer, Kilitch Healthcare India Limited, to voluntarily recall the product on Oct. 25. Some retailers like CVS, Rite Aid and Target pulled the products immediately, but Killitch didn't recall the eye drops until Nov. 15.

That delay concerns Rep. Frank Pallone (N.J.), the ranking Democrat on the House Energy & Commerce Committee. In addition to mandatory FDA recall authority, Pallone wants to require that drug labels include the names of their manufacturers. More from John.

Stat in DC

See you on Tuesday!

I hope to see all of you next Tuesday night at STAT's latest D.C. event.

The night will include an interview with former FDA Scott Gottlieb on the next pandemic, new drug developments, and of course, pricing policies. My colleague John Wilkerson will also lead a panel on persistent drug shortages with experts from academia, industry, and distributor channels. Both will take questions from the audience, so get your sharpest Qs ready.

If you're in town, I will also be there and would love to catch up at the reception afterwards. Sign up here.

eye on fda

First Opinion: FDA in the gene therapy crosshairs

Despite fast-paced gene therapy development and FDA promises to review dozens of upcoming therapies, the agency is far off pace with the industry, former Sen. Richard Burr writes in a new op-ed. Burr, who worked on legislation to accelerate gene therapy reviews as a North Carolina Republican, points to the agency's "risk averse approach and culture that's slow to adapt to new sciences."

For instance: Reviewers should recognize when randomized, double-blind, and placebo-controlled trials are unrealistic, and work more closely with developers on trial design, Burr argues. Read more from him.

health disparities

Asian-American data categories mask health disparities

People of Asian descent make up more than 60% of the world's population, including at least 25 million Americans. Yet in U.S. medical research and government health agencies from the NIH to the CDC, the diverse, far-ranging languages, cultures, and challenges are almost always grouped under the same racial category.

The main problem, as STAT's Usha Lee McFarling writes, is that when this highly diverse pool of Americans is blended together in widely used metrics, they seem to be doing very well — better than white Americans in important categories such as income, educational achievement, access to health insurance, and longevity.

But separate out subgroups of Asian Americans and outcomes are far poorer. Liver cancer is more than twice as common among Asian Americans than white Americans, but the rates for Laotian Americans are more than seven times higher than white Americans. Meanwhile diabetes rates are highest for Filipino and Asian Indian Americans.

There hasn't been much legislative action on this front. For example, there's been a bill floating around Congress for years now that would order health agencies to conduct more mental health studies among Asian-Americans, Native Hawaiians, and Pacific Islanders, but it hasn't gained traction. More from Usha.

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