This Week at FDA: Former FDA commissioners push for reforms cut from user fee package

This Week at FDAThis Week at FDA | 14 October 2022 |  By 

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 saw two former FDA commissioners, Scott Gottlieb and Mark McClellan, call on Congress to pass several legislative reforms that were stripped out of the user fee reauthorization package last month.
Writing in JAMA Forum this week, Gottlieb and McClellan said the agency’s oversight of dietary supplements, cosmetics and diagnostic tests needs to be overhauled to better protect patients as such products evolve. “All 3 industries are benefiting from technological advances that offer new opportunities to improve people’s health, but also create new uncertainties and risks. For each of these industries, evidence indicates that products that slipped through a porous regulatory framework have put some individuals at risk,” the two former commissioners wrote.
The Biden Administration is touting provisions in the Inflation Reduction Act passed earlier this year that would control Medicare drug prices by phasing in a cap for out-of-pocket pharmacy costs for certain drugs and vaccines, cap monthly insulin prescriptions to $35 and require companies that raise drug prices faster than inflation to pay a rebate. On Friday, Biden is expected to sign an Executive Order directing the Department of Health and Human Services (HHS) to take further steps to “drive down prescription drug costs,” including testing novel ways of paying for drugs through Medicare. The order will call for the department to issue a report within 90 days on its plans to leverage its Innovation Center to lower drug spending.
According to Reuters, FDA investigators recently uncovered new quality issues at Eli Lilly’s Branchburg, New Jersey facility. The news comes after the Department of Justice opened a criminal investigation into manufacturing practices at the facility spurred by an earlier Reuters investigation.  
Drugs & biologics
Earlier this week, FDA released data on its generic drugs and regenerative medicine advanced therapy (RMAT) programs, offering a look at the agency’s performance in FY2022.

In total, the agency approved 722 abbreviated new drug applications (ANDAs) and granted tentative approval to another 183 products, an uptick from the 679 approvals and 157 tentative approvals in FY2021. The agency also issued fewer complete responses to generic applicants, 1,670 in FY2022 compared to 1,851 in FY2021.
Looking at RMAT designations, FDA received a total of 30 requests for designation in FY2022, and the agency granted 12 and denied 13 of them; one request was withdrawn by the sponsor from consideration before the agency reached a decision. The agency has yet to withdraw a designation on its own accord.
FDA also revised its guidance ANDA Submissions – Prior Approval Supplements Under GDUFA on Friday to account for changes to the program under the recently reauthorized Generic Drug User Fee Amendments (GDUFA III) program.
And, FDA announced on Friday that it has issued six final administrative orders for over-the-counter (OTC) monographs using its authorities under the CARES Act.
Stat reports that FDA has settled a lawsuit filed by the Outsourcing Facilities Association on behalf of compounding pharmacies over the agency’s slow pace in adding ingredients to its 503B bulk drug substances list. According to Stat, the settlement requires FDA to prioritize its work on ingredients that have already been nominated to the list and could enable the availability of more compounded treatments.
FDA posted two recent waring letters to pharmaceutical companies for operating under unsanitary conditions and failing to comply with Current Good Manufacturing Practices (CGMP). The first company, Eksa Mills, based in Mexico was sent a letter on 5 October for failing to clean, sanitize and sterilize equipment and utensils used to make its drugs. The agency also sent a letter to Legacy Pharmaceutical Packaging in Missouri on 3 October stating its “drug products were prepared, packed, or held under insanitary conditions.”
The FDA will start accepting products into its total product lifecycle advisory program (TAP) pilot starting in January. However, the agency will only accept 15 cardiovascular breakthrough devices into the pilot program in the first year as part of what it is calling a soft launch. If all goes well, regulators will add on more offices of health technology and products that qualify for the pilot.


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