MATTHEW PERRONE Health Writer, Author at The Rapid City Post

FILE - The Food and Drug Administration seal is seen at the Hubert Humphrey Building Auditorium in Washington, April 22, 2025. (AP Photo/Jose Luis Magana, File)

FDA takes aim at Hims and other telehealth services in drug advertising blitz

September 16, 2025

The Trump administration has issued its first warnings to online services that offer unofficial versions of popular drugs like the blockbuster obesity treatment Wegovy. The Food and Drug Administration on Tuesday sent letters to Hims & Hers and dozens of other companies, ordering them to halt “false and misleading” statements about their medications. It’s the first time regulators have gone after online prescribing services, which don’t typically fall under FDA authority. The FDA says that Hims must drop language comparing its compounded drugs to brands like Wegovy, which are approved by the FDA.

FILE - The U.S. Food and Drug Administration campus in Silver Spring, Md., is photographed on Oct. 14, 2015. (AP Photo/Andrew Harnik, File)

Trump’s plan for a drug advertising crackdown faces many hurdles

September 10, 2025

Health Secretary Robert F. Kennedy Jr. and other administration officials are vowing to crack down on deceptive drug ads, but they may encounter some major obstacles. President Donald Trump signed a memo Tuesday directing the FDA and other agencies to enforce transparency in pharmaceutical promotions. The FDA plans to issue warnings to drugmakers over misleading ads. However, the agency faces challenges, including legal pushback and staffing cuts. The administration also says it wants to reverse a 1997 rule allowing brief summaries of drug risks in TV ads, but that process could take years. The agency also has long struggled to police social media promotions.

FILE - This undated photo provided by the U.S. Centers for Disease Control and Prevention (CDC) shows a blacklegged tick, also known as a deer tick, a carrier of Lyme disease. (CDC via AP, File)

Unproven Lyme disease tests and treatments are proliferating

September 10, 2025

The complexity of diagnosing Lyme disease has given rise to an entire industry of unapproved tests and alternative treatments, including lasers, herbal remedies and electromagnets. There is no simple approach to diagnosing Lyme. Doctors have to use a combination of visual clues and information from their patient in combination with the standard medical test, which has a number of limitations. Lyme experts warn that patients may spend hundreds or thousands of dollars on bogus tests, which aren’t covered by insurance. Those results can lead to treatment with unapproved therapies that may do more harm than good.

In this photo provided by the Department of Health and Human Secretary, Robert F. Kennedy, Jr., right, conducts the swearing-in ceremony of Jim O'Neill as the Department's Deputy Secretary, June 9, 2025, in Washington. (Amy Rossetti/Department of Health and Human Services via AP)

Trump’s new CDC chief: A Washington health insider with a libertarian streak

August 29, 2025

President Donald Trump has picked a former investor and critic of health regulations to oversee the Centers for Disease Control and Prevention. Jim O’Neill currently serves as the health department’s number two official under health secretary Robert F. Kennedy Jr. His additional appointment comes after a tumultuous week at the CDC in which the agency’s director was forced out over disputes with Kennedy. A former associate of billionaire tech entrepreneur Peter Thiel, O’Neill previously helped run one of Thiel’s investment funds. He also previously served in government under George W. Bush, making him an outlier among Trump’s team of health outsiders.

FILE - Food and Drug Administration (FDA) commissioner Marty Makary speaks during a news conference at the Hubert Humphrey Building Auditorium in Washington, April 22, 2025. (AP Photo/Jose Luis Magana, File)

FDA’s new expert panels are rife with financial conflicts and fringe views

August 18, 2025

A series of panels convened by the Food and Drug Administration is raising concerns that the agency is skirting federal rules and promoting fringe views about antidepressants and other products. The FDA has more than 30 panels of experts specializing in drugs, vaccines and other products. But increasingly, the agency isn’t calling them. Instead, FDA Commissioner Marty Makary is holding ad hoc sessions with outside experts who often have contrarian views and financial interests in the topics under discussion. The meetings have focused on issues of interest to Health Secretary Robert F. Kennedy Jr., including depression pills and talc powder.

U.S. Health Secretary Robert F. Kennedy Jr. attends a news conference, Tuesday, Aug. 5, 2025, in Anchorage, Alaska. (AP Photo/Mark Thiessen)

RFK Jr.’s vow to overhaul vaccine injury program echoes grievances of anti-vaccine movement

August 7, 2025

Health Secretary Robert F. Kennedy Jr. says he wants to rework the U.S. program for compensating Americans injured by vaccines. The plan has long been a target of anti-vaccine groups and changing it could have far-reaching consequences for vaccine availibility. Government officials set up the program in the 1980s to limit the legal risks for vaccine makers. At the time many companies were leaving the business due to class action lawsuits. Kennedy and other critics have complained that the program shields vaccine makers from litigation and is too stingy in compensating injured patients.

FDA flags problems with two Boston Scientific heart devices tied to injuries and deaths

August 6, 2025

U.S. health officials have issued warnings on two separate Boston Scientific heart devices recently linked to injuries and deaths. The agency said Wednesday an issue with defibrillator wires could cause the implants to fail to deliver adequate electrical shocks. The company warned doctors about the issue last month. Separately, the FDA flagged updated instructions for the company’s Watchman heart implant, which is used to reduce the risk of stroke. Boston Scientific said it has seen an increased risk of dangerous blockages in the bloodstream depending on how the device is implanted. The company says the problem is not related to the device design.

In this undated photo provided by the U.S. Food and Drug Administration, Vinay Prasad smiles for a portrait. (U.S. FDA via AP)

FDA vaccine chief leaving agency after less than 3 months

July 30, 2025

Dr. Vinay Prasad is stepping down as the Food and Drug Administration’s top vaccine regulator after a brief tenure. A spokesperson for the Department of Health and Human Services says Prasad did not want to be a distraction and is leaving to spend more time with his family. Prasad, a longtime critic of the FDA’s leniency in drug approvals, joined the agency in May. He has faced scrutiny over his handling of a gene therapy for a form of muscular dystrophy. In recent weeks he became a target of conservative activists, who noted his past comments criticizing Trump.

Sarepta will resume gene therapy shipments after FDA review of recent patient death

July 28, 2025

Shares of drugmaker Sarepta Therapeutics surged in afterhours trading Monday after the company said it would resume shipping its gene therapy. The company’s stock has been under pressure for weeks after a series of patient deaths prompted federal regulators to request a pause on the drug’s use. Elevidys is the first gene therapy approved in the U.S. for Duchenne’s muscular dystrophy, the fatal muscle-wasting disease that affects boys. The Food and Drug Administration said late Monday it recommended resuming shipments for some patients after reviewing the situation. The review included the conclusion that the recent death of an 8-year-old boy was unrelated to the company’s therapy.

FILE - The Food and Drug Administration seal is seen at the Hubert Humphrey Building Auditorium in Washington, Tuesday, April 22, 2025. (AP Photo/Jose Luis Magana, File)

Sarepta shares slide again as drugmaker bows to FDA pressure to pause gene therapy

July 22, 2025

Sarepta Therapeutics is pausing shipments of its gene therapy for muscular dystrophy following several patient deaths that have attracted attention from regulators. The company said late Monday it would comply with a Food and Drug Administration request to halt distribution of Elevidys. The decision comes just days after the company rebuffed FDA regulators in an extremely unusual decision. Elevidys is the first gene therapy approved in the U.S. for Duchenne’s muscular dystrophy. The fatal muscle-wasting disease affects boys and young men, resulting in early death. Company shares continued to slide in early trading Tuesday morning.

FDA names former pharmaceutical company executive to oversee US drug program

July 21, 2025

The Food and Drug Administration named a longtime pharmaceutical executive to run the agency’s drug program. Dr. George Tidmarsh is the founder and former CEO of several drugmakers. He was named Monday to run the FDA’s center for drugs, which employees nearly 6,000 staffers. His appointment comes a month after the center’s acting director announced her retirement. As the agency’s top drug regulator, Tidmarsh would be tasked with following through on a number of commitments by the Trump administration. That includes reviewing the 25-year-old approval of the abortion pill mifepristone.

Gene therapy maker Sarepta tells FDA it won’t halt shipments despite patient deaths

July 19, 2025

Drugmaker Sarepta Therapeutics says it won’t comply with a request from U.S. regulators to halt all shipments of its gene therapy. The Food and Drug Administration made the request Friday after the confirmation of a third death receiving one of its treatments for muscular dystrophy. The company’s decision not to comply is highly unusual. The FDA says officials met with Sarepta executives and requested the halt in sales. Sarepta says in a statement that its scientific review showed no new safety concerns for younger patients with Duchenne’s muscular dystrophy. The company said it plans to keep the drug, Elevidys, available for those patients.

FDA requires updated warning about rare heart risk with COVID shots

June 25, 2025

U.S. health officials have expanded warnings about a rare heart side effect associated with the two leading COVID-19 vaccines. The Food and Drug Administration announced the update Wednesday, providing more detail about the problem and the number of people who may be affected. Pfizer and Moderna have added the information to their labels and pamphlets for patients. Myocarditis, a type of heart inflammation that is usually mild, emerged as a rare effect with the first COVID-19 shots, mainly in boys and young men. Earlier vaccine labeling advised doctors about the issue. The new warning covers a larger group.

FDA to offer faster drug reviews to companies promoting ‘national priorities’

June 17, 2025

The Food and Drug Administration says it will begin offering faster reviews to new medicines that align with Trump administration priorities for Americans’ health. The new program announced Tuesday aims to review select drugs in just one to two months. It was announced by FDA Commissioner Marty Makary, who has promised “faster cures” since arriving at the agency in April. Makary says the FDA will begin offering special vouchers to drugmakers who are “aligned with U.S. national priorities.” The FDA already has a variety of programs designed to speed up drug reviews, but they all have fairly strict medical criteria.

FILE - The U.S. Food and Drug Administration campus in Silver Spring, Md., is photographed, Oct. 14, 2015. (AP Photo/Andrew Harnik, File)

Second patient death reported with gene therapy for muscular dystrophy

June 16, 2025

Shares of Sarepta Therapeutics have plunged again after the drugmaker reported a second death in connection with its gene therapy for muscular dystrophy. The biotech drugmaker said Sunday it was pausing shipments of the drug for patients who are no longer able to walk. The one-time treatment is the first gene therapy approved in the U.S. for the rare muscle-wasting condition. The company has faced scrutiny since its accelerated approval in 2023. Sarepta says it will pause a study of the therapy and assemble an expert panel to recommend new safety protocols for taking the drug.

This photo provided by the FDA in January 2024 shows bottles of Neptunes Fix Elixir, a product labeled to contain tianeptine. (FDA Office of Regulatory Affairs, Health Fraud Branch via AP)

‘Gas station heroin’ is technically illegal and widely available. Here are the facts

June 14, 2025

Health officials want you to think twice before buying brightly colored energy shots and supplements often sold at gas stations, convenience stores and smoke shops. The products are sometimes called “gas station heroin,” and contain tianeptine. That’s an antidepressant that can be addictive and carries the risk of serious side effects. U.S. poison control centers have reported a steady rise in calls linked to the drug for more than a decade. The drug has never been approved by the FDA for any medical condition in the U.S. and cannot legally be added to foods and beverages or sold as a dietary supplement. About a dozen states have prohibited or restricted tianeptine.

MATTHEW PERRONE Health Writer.