News: A day in the sun for a new sunscreen?

Friday, May 31, 2024

A day in the sun for a new sunscreen?

May 31, 2024

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By Lauren Gardner and David Lim

With Carmen Paun

Driving The Day

Rep. John Joyce speaks.

Rep. John Joyce says FDA red tape has kept Americans from accessing new and innovative sunscreens. | Andrew Harnik/AP

HANGING BACK IN THE SHADE — Last weekend marked the unofficial start of summer in the U.S., but one thing that didn’t change with the season was the number of sunscreen ingredients available to consumers here.

Over the last decade, Congress has twice tried to prod the FDA toward endorsing some of the sunscreen filters found in European and Asian markets that feel less greasy and more easily blend into darker skin tones. But the agency hasn’t approved a new ingredient since 1999, and only one company is close to getting regulators to review its application for a substance long available overseas, Lauren reports.

Why? The FDA regulates sunscreen as an over-the-counter drug because of health claims about the product's ability to prevent skin cancer and aging, which requires animal testing to prove their safety. Meanwhile, other countries regulate sunscreen as a cosmetic subject to less stringent review.

The industry has tried to get the FDA to back off its animal-testing requirements, arguing alternative tests are sufficient to establish safety, but to no avail. Some companies have bowed out of the regulatory gauntlet for their sunscreens, while others are reluctantly moving ahead.

The FDA argues that animal testing is necessary for sunscreens given recent research showing that more of the chemicals than was previously known are absorbed into the body’s bloodstream instead of sitting on top of the skin.

The pushback: Some public health experts say plenty of data exists around sunscreens’ use worldwide — and on the sun’s carcinogenic effects — to show that the benefits of the products outweigh their risks. Having more options available could entice more people to wear sunscreen every day, they say.

But the FDA says that the prospect of daily use means it’s crucial for the agency to have data showing the products’ safety over the long term.

Despite the lag, Congress isn’t considering new legislation on the issue. But Rep. John Joyce (R-Pa.) wants to help the FDA and industry hash out a compromise.

To him, it’s personal: Joyce is a dermatologist and a skin cancer survivor.

More than 200 congressional staffers and members were screened for skin cancer in the Capitol this month, Joyce said. Four suspicious lesions were evaluated for melanoma, he said, the deadliest form of skin cancer.

“The rest of the world has moved ahead of us,” he said.

IT’S FRIDAY. WELCOME BACK TO PRESCRIPTION PULSE. This take on the use of eggs in avian flu vaccines has us clucking (sorry).

Send news and tips to David Lim (dlim@politico.com or @davidalim) and Lauren Gardner (lgardner@politico.com or @Gardner_LM).

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Eye on the FDA

A sign for the Food And Drug Administration is seen.

A reorganization is in store for the FDA. | Sarah Silbiger/Getty Images

HHS BLESSES FDA REORG — HHS Secretary Xavier Becerra has signed off on the FDA’s proposed reorganization, paving the way for the agency to implement a major office shuffle by the fall.

The endorsement, which will be published in the Federal Register on Monday, was the last step needed for the agency to make its revamp a reality.

Alphabet soup refresher: The Office of Regulatory Affairs will become the Office of Inspections and Investigations to realign the focus of the FDA’s field operations. The reorganization will also streamline several of the agency’s food oversight arms into one human foods program.

BIRD FLU

ANOTHER CASE — The CDC and Michigan’s Department of Health and Human Services announced a third human case of avian influenza Thursday tied to the current outbreak among dairy cows.

“The bottom line is this: This newest case does not change CDC’s H5 influenza risk assessment level for the general public, which remains low,” Dr. Nirav Shah, the CDC’s principal deputy director, said. “And that’s because all three individuals diagnosed with H5 flu [have had] direct exposures to affected cows.”

The infection, the second in the state, is in a dairy worker who is the first to experience respiratory symptoms such as cough, congestion and sore throat in the current outbreak.

“With this case, respiratory symptoms occurred after direct exposure to an infected cow. Neither individual was wearing full personal protective equipment,” said Natasha Bagdasarian, Michigan’s chief medical executive. “This tells us that direct exposure to infected livestock poses a risk to humans and that PPE is an important tool in preventing spread among individuals who work on dairy and poultry farms.”

FDA angle: The FDA recently granted the CDC’s request to add eye swabs to the H5 subtyping kit, Shah told reporters. That means that more testing can be done at the local level instead of by the CDC.

“The faster that we can get to even a preliminary result on the ground, the faster that public health action can be started,” Shah said.

Industry Intel

ONE SIZE DOESN’T FIT ALL — GLP-1s are revolutionizing obesity treatment, but the health care system should take a more individualized approach when determining the best candidates to take the drugs and get them covered by insurance.

That was the takeaway from an expert panel Lauren moderated this week at The Healthcare Innovation Congress in Washington. Here are some highlights from the conversation:

— “Lifestyle management” is part of the toolkit. The FDA-approved indications for weight-loss drugs Wegovy and Zepbound include diet and exercise as part of the treatment. But those strategies are also tricky — they were long the main treatment options for obesity, and providers and payers alike have to figure out a balance between how those approaches are used alongside medications.

“To put it simply, it’s not just behavior change to get weight loss — it’s behavior change to make sure that it’s not just weight loss, but healthy weight loss, and what that means for patients as we listen to them,” said Gary Foster, chief science officer at WeightWatchers (WW), “because they don't want to lose 50 pounds and be weaker.”

— Employers need options to bring down costs. They’re using different types of “guardrails” to try to offer the drugs under their insurance plans to patients with the best chances for success, but some pharmacy benefit managers are balking at those approaches, said Shawn Gremminger, president and CEO of the National Alliance of Healthcare Purchaser Coalitions.

“To me, the only answer here is, let’s provide the resources that they need around them so that they stick with the drug that they’re making the changes they need to make, and they are actually seeing the clinical benefit they need in the long run,” he said.

Pharma Worldwide

MPOX SHOT TO BE TESTED IN AFRICA — An international organization working to develop vaccines against pathogens with pandemic potential awarded $6.5 million to Bavarian Nordic, the Danish company that manufactures the mpox vaccine Jynneos, to test the shot in children living in endemic countries in Africa.

The Coalition for Epidemic Preparedness Innovations will sponsor a vaccine trial in children between ages 2 and 12, which are the most impacted by an ongoing mpox outbreak in the Democratic Republic of the Congo.

Document Drawer

The FDA seeks civil money penalties from nine brick-and-mortar retailers and one online seller of Elf Bar.

The FDA issued draft guidance containing details on the implementation of the platform technology designation program for drug development.

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