This Week at FDA: USPTO, FDA align on drug competition, Paxlovid from your pharmacist, and more

This Week at FDAThis Week at FDA
| 08 July 2022 | By Michael Mezher 

Welcome to another installment of This Week at FDA, your weekly source for updates – big and small – on FDA, drug and medical device regulation, and what we’re reading from around the web. This week, we learned that FDA is looking to hire a media-savvy physician to direct its communication strategy. The agency also authorized state-licensed physicians to prescribe Pfizer’s COVID-19 antiviral drug. Plus, we read that FDA and the US Patent and Trademark Office (USPTO) are planning to work more closely to promote drug competition.
 
After learning of two high-profile hires at FDA last week, we read that FDA is eyeing Vin Gupta, a pulmonologist and Chief Medical Officer at Amazon, who also appears as a medical analyst for NBC and MSNBC, to serve as the agency’s principal medical adviser. According to Politico, Gupta would be tasked with steering the agency’s communication strategy and acting as a “public face on high-profile issues and trying to bolster trust in the agency’s health recommendations.”
 
Senate Democrats are reportedly working to advance legislation that would enable Medicare to negotiate prescription drug prices, according to Reuters. The news outlet reports that all 50 Senate Democrats are in line on the proposal, and according to Politico, the proposal has been sent to the Senate Parliamentarian for review as part of a larger reconciliation package.
 
To ease access to Pfizer’s COVID-19 antiviral drug Paxlovid (nirmatrelvir and ritonavir), FDA on Wednesday moved to allow state-licensed pharmacists under certain circumstances. “Since Paxlovid must be taken within five days after symptoms begin, authorizing state-licensed pharmacists to prescribe Paxlovid could expand access to timely treatment for some patients who are eligible to receive this drug for the treatment of COVID-19,” said Center for Drug Evaluation and Research Director Patrizia Cavazzoni. The same will not be true for Merck’s Lagevrio (molnupiravir), Fierce Pharma reports.
 
We’re also reading this blog from USPTO Director Kathi Vidal and FDA Commissioner Robert Califf on the two agencies’ efforts to “promote competition and lower drug prices for all Americans.” The two agency heads said that more work is needed to ensure that the patent system is not used to “unjustifiably delay generic drugs and biosimilar competition beyond that reasonably contemplated by law.” The two said their agencies will work more closely with the aim of protecting “against the patenting of incremental, obvious changes to existing drugs that do not qualify for patents.”
 
Drugs & biologics
 
This week, we learned that FDA will reconvene its Peripheral and Central Nervous System Drugs Advisory Committee (PCNSDAC) to review Amylyx Pharmaceuticals’ amyotrophic lateral sclerosis (ALS) drug known as AMX0035 for a second time in September. The rare move comes after the agency extended its Prescription Drug User Fee Act (PDUFA) goal date for the drug. In March, the PCNSDAC voted 6-4 against approving the drug, Stat reported.
 
The agency also granted Biogen and Eisai’s Alzheimer’s disease drug lecanemab priority review under the accelerated approval pathway, with a PDUFA goal date of 6 January 2023. The news follows the agency’s controversial decision to grant accelerated approval to the pair’s other Alzheimer’s drug Aduhelm (aducanumab) last June.
 
We also saw FDA’s Office of New Drugs (OND) release its 2021 annual report detailing its activities and accomplishments during the calendar year.
 
FDA announced on Friday it is withdrawing Xellia Pharmaceuticals’ abbreviated new drug application for bacitracin for injection, 50,000 units/vial, at the company’s request. The withdrawal comes after the agency’s Antimicrobial Drugs Advisory Committee voted almost unanimously that the drug’s risks outweigh its benefits for its sole approved indication in April 2019. The agency called for companies to voluntarily withdraw their applications for the drug in early 2020.
 
FDA has released new quarterly data on its regenerative medicine advance therapy (RMAT) designation, which shows that the agency received 21 requests so far in FY2022, compared to a total of 24 requests in all of FY2021. The agency has already granted 9 of those requests, already exceeding the number granted in the previous year.
 
Medical devices
 
FDA has identified Getinge USA’s recall of its Flow-c and Flow-e anesthesia systems as a Class I recall due to the risk of cracked or broken suction system power switches, which could cause delays during procedures or between procedures, and could cause choking, inability of oxygen to get into the blood, pneumonia, brain injury or death. FDA said it has received 21 complaints related to the issue, though none that cited injury or death.
 
We’re also looking forward to FDA’s upcoming Patient Engagement Advisory Committee meeting next Tuesday and Wednesday. The committee will be tasked with making recommendations related to augmented reality (AR) and virtual reality (VR) medical devices.

 

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