Medicine

WASHINGTON — The head of the Food and Drug Administration, Dr. Marty Makary, is resigning after a rocky tenure that drew months of complaints from health industry executives, anti-abortion activists, vaping lobbyists and other allies of President Trump.

He steps down after just over a year leading the powerful health regulatory agency, according to a White House official who was not authorized to speak before an announcement expected Tuesday and requested anonymity.

Kyle Diamantas, the agency’s chief for foods, will take over as acting commissioner, the official said. Diamantas is an attorney with personal ties to Donald Trump Jr.

A surgeon and health researcher, Makary came to prominence among Republicans as an outspoken critic of COVID-19 health measures during the pandemic when he frequently appeared on Fox News.

But he struggled to manage the FDA’s bureaucracy and failed to win the confidence of its staff after mass layoffs, leadership changes and a series of controversies in which the agency’s scientific principles appeared to be overridden by political interests, including those of Health Secretary Robert F. Kennedy Jr.

The FDA commissioner, as the leader of an agency that regulates billions of dollars in consumer goods and medicines, is often required to juggle competing priorities that straddle science and politics.

Makary faced a unique challenge in balancing calls by Trump and other Republicans to cut red tape at the FDA, while also tending to Kennedy’s interest in scrutinizing the safety of vaccines, drugs and food additives.

Virtually all of the FDA’s senior career officials resigned, retired or were forced out in the first year of the second-term Trump administration, leading to a steady stream of leaks and negative stories in the media cataloging low morale, dysfunction and frustration among staff.

Makary’s handpicked deputy, Dr. Vinay Prasad, was pushed out of the agency twice in less than a year for running afoul of specialty drugmakers and groups for patients with rare diseases. Makary appeared poised to weather the controversy, despite an ongoing pressure campaign calling on Trump to fire him.

Recent months brought fresh criticisms from other interest groups that the White House considers key to Republican chances in November elections.

Anti-abortion groups have criticized Makary for allegedly slow-walking an internal review of the abortion pill mifepristone, which has been on the market for 25 years but remains a target for conservative activists.

Vaping executives told Trump that Makary was blocking approval of their products, including new flavored e-cigarettes seen as crucial to the industry’s survival.

Last week, the agency abruptly changed course on vaping: authorizing the first fruit-flavored products and issuing guidelines that loosened marketing for major manufacturers. But it wasn’t enough to keep Makary in the job.

A permanent replacement for FDA commissioner will need to be nominated by Trump and confirmed by a majority vote in the Senate.

Faster drug reviews are overshadowed

As a former regular on Fox News, Makary was aggressive about promoting his accomplishments on cable television and podcasts and in online opinion pieces.

More than a half-dozen initiatives from Makary aimed to speed up or streamline FDA drug reviews, including dropping certain study requirements, incorporating artificial intelligence into drug evaluations and offering expedited reviews to medicines that support “national interests.”

But pharmaceutical executives rely on the predictability and consistency of FDA decisions, even more than speedy reviews. Makary’s efforts on drug reviews were overshadowed by internal conflicts and upheavals that created headaches for drugmakers, investors and patients.

A number of specialty drugmakers studying therapies for rare or hard-to-treat diseases said they received rejection letters or requests to run additional studies for drugs that previously had been given the go-ahead by FDA staff. Those drugs were primarily overseen by Prasad, who stepped down for a second time from his role as FDA’s vaccine and biotech chief in April.

Vaccine moves denounced

Prasad repeatedly overruled vaccine staffers to restrict eligibility for new COVID shots. In February, Prasad initially refused to even consider Moderna’s mRNA shot for flu. The FDA was forced to reverse itself after Moderna pledged to formally challenge the decision and called for intervention by the White House.

Some of Makary and Prasad’s most controversial vaccine proposals never came to fruition, despite stoking confusion and anxiety within the FDA and beyond.

In an internal memo in November, Prasad claimed — without publishing evidence — that the FDA had linked COVID shots to the deaths of 10 children. Prasad used that to justify a planned wholesale overhaul of the agency’s approach to approving and updating vaccines.

A dozen former FDA commissioners issued a scathing denunciation of the plan, warning that it would “undermine the public interest” and decimate vaccine development. The FDA has not released its analysis of the deaths or its plan for the vaccine overhaul.

FDA’s drug center had a revolving door

In the FDA’s drug center, which is the agency’s largest division, Makary oversaw a revolving door of leadership changes. Six people served as director over the course of one year.

Makary’s initial pick for the job, Dr. George Tidmarsh, was forced to resign after allegations that he used his FDA position to pursue a personal vendetta against a former business partner.

His replacement, longtime FDA cancer specialist Dr. Rick Pazdur, announced he would retire after just three weeks on the job, after clashing with Makary on multiple issues involving drug reviews.

With Makary’s departure, the fate of many fledgling initiatives is uncertain.

Most of the programs Makary introduced have not gone through federal rulemaking required to enshrine them in U.S. regulations and could easily be overturned by his successors.

Democrats in Congress have questioned the legality of some of those efforts, including a program that offers drugmakers expedited reviews for innovative medicines.

Perrone and Kim write for the Associated Press.

The airline advises passengers to avoid putting it in their hold luggage if possible

EasyJet says passengers should keep one type of item with them, ideally in their hand luggage rather than their check-in bags. All passengers can bring one small under-seat cabin bag per person on board for free. It can be a maximum size of 45 x 36 x 20 cm (including any handles and wheels) and must be kept under the seat in front of you.

Regarding what travellers should keep in their hand luggage or handbags, the airline stresses the importance of carrying any medication so it’s always within reach. A statement on EasyJet‘s website reads: “We do advise you to pack your medication in your hand luggage where possible, especially if it is medication that you may need to take during the flight.”

In an additional note, the airline says: “If you pack medicines in your hold luggage, we do not require a letter from your healthcare practitioner.” It adds: “We’re unable to refrigerate medication on board.”

There are certain types of medication and equipment passengers can bring on board. EasyJet says: “If you need to bring medication with you, please pack it in your cabin bag wherever possible.” A letter from your healthcare practitioner is only required if you are bringing any of the following items on board:

• Liquids that exceed 100ml.
• Sharp objects such as needles.
• Oxygen cylinders and concentrators.
• Any medical equipment that may be considered as dangerous goods in the aircraft cabin, a list of which can be found here.

EasyJet explains: “The letter should confirm that this medication is prescribed to you and it’s necessary for you to bring the items on board. We do not require a letter from your healthcare practitioner for all other medications and equipment.”

These include gel packs and cooler bags to maintain the temperature of your medication. As well as food and specialist devices such as dialysis machines (subject to size regulations), CPAP machines and nebulisers.

If travelling with medication containing a controlled drug, EasyJet advises passengers to check with their doctor or pharmacist if their prescription contains a controlled drug, as some countries have strict laws regarding these medications. Controlled drugs are medications that are subject to high levels of regulation as a result of government decisions, such as Diazepam, Lorazepam, Codeine or Tramadol.

EasyJet said: “If you need to travel with medicine that contains a controlled drug, please check the embassy rules for the country you’re travelling to, as well as the entry requirements before you fly. You will need to prove your medication is yours, either with a prescription or a letter from your doctor.”

Crutches and walking frames can be brought on board. EasyJet’s cabin crew can store them and return them after landing. Walking frames can be stored on board if space is available, or they will be put into the aircraft hold and returned after landing.

Portable medical equipment can be brought on board in addition to your cabin bag allowance. Portable medical devices must be no larger than 56 x 45 x 25 cm, otherwise they will have to travel in the hold. If you need to carry a small portable medical device, such as:

• CPAP machines
• TENS machines
• Nebulisers
• Portable dialysis machines

EasyJet said: “Then this may be carried in addition to your cabin bag allowance, provided that it’s no larger than 56 x 45 x 25 cm and that you have informed our Special Assistance Team, at least 48 hours before your flight that you require an additional medical bag for your journey. Non-essential medical equipment which exceeds your cabin-bag allowance will be charged in line with our baggage policy and may need to be placed in the hold.

“If you need to bring several medical devices or a large piece of medical equipment, please contact our Special Assistance team at least 48 hours before your flight so that they can advise you.”