RAPS recognizes that the current situation in Ukraine impacts our members and customers on many levels. If you are directly impacted by the current situation in the region and are challenged to meet your deadlines or obligations to RAPS, please reach out to raps@raps.org so that we can defer those challenges. Your health and safety are paramount to us.

Regulatory Focus™ > News Articles > 2022 > 1 > This Week at FDA: Generic drug approvals continue downward trend, new guidance on clinical trial div

This Week at FDA: Generic drug approvals continue downward trend, new guidance on clinical trial diversity coming

Posted 21 January 2022 | By Michael Mezher 

This Week at FDA: Generic drug approvals continue downward trend, new guidance on clinical trial diversity coming

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 look at some newly published data from FDA on its user fee program performance, REMS programs and generic drug approvals.
 
A new FDA guidance on diversity plans to improve the enrollment of underrepresented racial and ethnic groups in clinical trials may see the light of day soon. The guidance is currently pending review by the Office of Management and Budget (OMB). While there is no timeline for how long the review could take before the guidance is released, the document would build on other recent efforts to improve clinical trial diversity.
 
The agency has also announced the availability of a new draft guidance for its staff and industry relating to the requirements for FDA staff to collect samples of products and to provide a part of said samples to their owners or other authorized agents.
 
Drugs and biologics
 
For the data folks out there, FDA released a trove of data on its user fee performance for its human and animal drug review programs for FY2020 and preliminary results for FY2021. The new data is available on FDA-TRACK.
 
The agency also launched a new public dashboard for drugs with an approved risk evaluation and mitigation strategy (REMS). “FDA has approved nearly 300 REMS programs and more than 700 REMS modifications since 2008. This new dashboard includes visualizations and charts for total and active REMS programs, elements to assure safe use, REMS modifications, revisions, and released REMS programs that are no longer in effect,” FDA said.
 
Generic drug approvals continue their downward trend from last two years, according to FDA’s latest monthly performance report. In the first quarter of FY2022, the agency approved 150 abbreviated new drug applications (ANDAs). If that pace continues for the rest of the year, it will put the agency on track to approve the fewest generic drugs in years.
 
Medical devices
 
FDA has placed all types of blood specimen collection tubes on its medical device shortage list, due to increased demand during the COVID-19 pandemic. The agency has published a questions and answers page addressing the shortage and has sent a letter to healthcare and laboratory personnel offering recommendations to conserve the devices.
 
Additionally, the agency has issued classification orders for several types of devices, including electrocardiograph software for over-the-counter use, retinal diagnostic software devices and human leukocyte, neutrophil and platelet antigen and antibody tests.
 
A recall for the Vaporizer Sevoflurane component of Getinge’s Maquet Flow Family anesthesia gas machines has been identified as a Class I recall. FDA says the recall was prompted by a “potential breakdown of Sevoflurane … that may result in inhalation and/or skin exposure to harmful chemicals.” The agency says it has received eight complaints about the issue but has not been notified of any reported deaths or injuries.
 
What we’re reading
 
Politico reports that a recent FDA decision to lift certain restrictions on accessing the abortion drug mifepristone, and the agency’s decisions involving the drug during Robert Califf’s previous tenure at the agency, may endanger his chances at being confirmed. The issue was raised by Republican senators during Califf’s confirmation hearing in December just days before FDA eased the restrictions.
 
We’re also reading in Endpoints about a new Republican-led bill in the Senate that would “even the playing field” for domestic and foreign inspections, so say sponsors Sens. Joni Ernst (R-IA) and Mike Braun (R-IN).
 
This study appearing in JAMA Internal Medicine from researchers at Harvard Medical School and the Program On Regulation, Therapeutics, And Law (PORTAL), finds FDA’s Unapproved Drugs Initiative is “no longer an effective means to encourage manufacturers to voluntarily submit safety and effectiveness data” 15 years after the program’s launch. The program was put on ice during the Trump administration but HHS recently withdrew the notice terminating the program.
 
Enforcement corner
 
FDA has released a handful of warning letters and a couple of Form 483s over the last week. The agency also sent a warning letter to a subsidiary of Indian generic drugmaker Aurobindo that has yet to be released to the public, according to Endpoints.
 
Sunstar Americas was warned last month for multiple violations at its drug and medical device facility in Schaumburg, Illinois, where the company makes its Hydral OTC products for treating xerostomia, or dry mouth. The warning letter lists both drug current good manufacturing practice (cGMP) and medical device quality system regulation violations.
 
The agency also released a Form 483 it handed to Catalent Belgium following an inspection of its 265,000 square-foot facility in Brussels in October 2021. The 483 lists seven observations that reportedly led to supply issues for Novo Nordisk’s Wegovy (semaglutide) pens. Some of the observations include a failure to adequately assess an unexplained discrepancy or deviation, failure to adequately establish validation plans to prevent contamination of sterile drugs and an inadequate procedure for preventing contamination during aseptic processing.
 
The agency also warned a Texas-based outsourcing facility for failing to meet the conditions of Section 503B of the Food, Drug, and Cosmetic Act. Some of the violations include not listing the National Drug Code number on the label of some of its products and failing to mention all the drug products it compounded during the six months prior to its initial registration with the agency.

 

© 2022 Regulatory Affairs Professionals Society.