A new FDA drug regulator will face a distrustful staff

On Monday, Tracy Beth Høeg will become acting director of the FDA's drug center.

She's the fifth director this year, and staff desperately want the drug center to be stable again. But based on her track record, agency workers fear Høeg will bring bias and more uncertainty to the center.

Traditionally, the CDER director position has gone to civil servants with significant regulatory, drug development, and management experience. Høeg doesn't have those traditional qualifications. She's a sports medicine physician and Ph.D. epidemiologist who grew close with Commissioner Marty Makary over their mutual skepticism of Covid boosters and other countermeasures.

Already at the FDA, Høeg has taken steps to limit access to Covid shots, cut career staff out of vaccine surveillance research, instructed staff to revisit the safety of monoclonal antibodies that protect infants against RSV, spoken at length about the risks of certain antidepressants for pregnant women without considering the benefits, and advised the CDC to cut down its childhood vaccine schedule.

pharma

Europe proposes shortening drug exclusivity period

European policymakers yesterday unveiled a sweeping proposal for the biggest shakeup to E.U. pharmaceutical policy in two decades.

Officials said the plan, by streamlining regulatory requirements and accelerating assessments, would benefit the drug industry. But pharma companies took particular issue with one section of the proposal related to drug exclusivity.

Currently, new drugs in Europe generally have 10 years of baseline exclusivity. Under the plan, the period would drop to nine years, but drugmakers could win additional years if they tick certain boxes — for example, by filling an unmet medical need or running trials in European countries. The maximum protection period is capped at 11 years.

infectious disease

GSK's antibiotic approved to treat gonorrhea

The FDA yesterday approved GSK's antibiotic Blujepa as a treatment for gonorrhea, the first new drug cleared to use against the infection in decades.

Gonorrhea is the second most commonly diagnosed sexually transmitted infection in the U.S., and it's notorious for developing resistance to antibiotics. Up until yesterday, there was just one drug on the market, ceftriaxone, that doctors could use against the infection.

Blujepa, which was first approved earlier this year to treat urinary tract infections, is part of a new class of antibiotics.