The Regulator

$210 million: that is the price Ultragenyx agreed October 7 to sell one rare pediatric disease priority review voucher for, and FDA put another one in the hands of Ionis Pharmaceuticals in a notice published October 9. The Food and Drug Administration (FDA) issued the voucher to Ionis, a maker of genetic medicines, with the October 9 approval notice for Zanvastro (zilganersen), cleared September 3 for Alexander disease, a rare inherited brain disorder. A voucher is a transferable ticket that speeds FDA review of a later drug, which is why drugmakers sell them: Ultragenyx’s deal for a voucher earned on its glycogen storage disease therapy Genglycos is still subject to antitrust waiting-period clearance, and the company’s last disclosed voucher sale, in 2017, brought $130 million. The FDA notice does not price the Ionis voucher or say whether Ionis will sell it, so treat any sale as unannounced. Confidence: High that the voucher was issued and the Ultragenyx price was announced; Low on what Ionis does next. Sources: Federal Register, Issuance of Priority Review Voucher, Zanvastro, Ultragenyx press release.

FDA formally classified at-home sexually transmitted infection (STI) test kits as moderate-risk devices, an order that took effect October 9 and lowers the bar for copycat products. The final order codifies a classification FDA first made November 15, 2023, for the Simple 2 Test from LetsGetChecked, in which a person collects their own sample at home and a clinical laboratory runs it. The device type is now class II with special controls under 21 CFR 866.3385, so later makers can file the cheaper 510(k) clearance, pointing to this test as a predicate, instead of a full De Novo request. Requirements include a clinical study using self-collected samples, shipping and collection instructions, and a labeling link to the maker’s website. The order is not exempt from 510(k), so every new kit still needs FDA clearance before sale. Confidence: High. Source: Federal Register, Classification of the System for Detection of Nucleic Acid From Non-Viral Microorganisms Causing Sexually Transmitted Infections.

FDA made the same move for over-the-counter infant oxygen monitors, classifying the Owlet Dream Sock type of device as class II effective October 9. The Federal Register order covers pulse rate and blood oxygen monitors for babies that use light sensors and may sound alarms, and it follows the November 8, 2023 decision on Owlet Baby Care’s request. Special controls require testing that accounts for skin pigmentation, software validation, alarm testing, biocompatibility, and labeling a caregiver can follow without help. Rivals still need 510(k) clearance, but can now cite the Owlet product as the comparison device. Confidence: High. Source: Federal Register, Classification of the Infant Pulse Rate and Oxygen Saturation Monitor for Over-the-Counter Use.

FDA withdrew approval of 37 generic drug applications from Par Health and affiliated applicants, plus Amneal’s celecoxib capsules, all at the companies’ request, in notices dated October 9. The Federal Register notices say the products are no longer marketed, so the withdrawals remove paper approvals rather than drugs pharmacies are stocking; the agency does not list sales volumes. FDA also determined that LASIX (furosemide) oral solution, 10 milligrams per milliliter, was not withdrawn for safety or effectiveness reasons, which keeps the door open for generic versions of the liquid water pill. The so-what for pharmacies and purchasers: check ordering lists, because a withdrawn application means that product can no longer legally ship. Confidence: High on the withdrawals; Med on market impact, which the notices do not quantify. Sources: Federal Register, Par Health USA withdrawal of 37 applications, Federal Register, Amneal celecoxib withdrawal, Federal Register, LASIX oral solution determination.

The Department of Health and Human Services (HHS) opened public comment, through November 12, on new steps and muscle-strengthening guidance to supplement the federal Physical Activity Guidelines for Americans. The Federal Register notice, published October 13, asks for written comments by 11:59 p.m. Eastern on November 12 to inform a 2027 supplement to the guidelines’ second edition. Federal physical activity guidance feeds school, community health and wellness programs and benefit design, so the step-count and strength recommendations HHS settles on will be cited for years. Confidence: High on the comment deadline; Low on what the final numbers will be. Source: Federal Register, Solicitation of Written Comments, Physical Activity Guidelines for Americans.