This Week at FDA: First OTC birth control pill approved, lawmakers advance PAHPA, and more

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, FDA approved the first over-the-counter birth control pill that doesn’t require prescription, lawmakers pushed a key pandemic bill forward and some US senators are withholding support for Biden’s nominee to lead the National Institutes of Health (NIH).

FDA this week approved the first birth control drug Opill (norgestrel) that can be sold over-the-counter and without a prescription. The agency says approval of Perrigo’s tablet will increase access to birth control for many people who otherwise would need to first get a prescription from a health care provider.

In Congress, House Energy and Commerce (E&C) health subcommittee advanced a stripped-down Pandemic and All Hazards Preparedness Act (PAHPA) reauthorization bill to the full committee. The bill moved forward along party lines, but lawmakers say they hope to work together on a bipartisan package, though neither side has shown signs of budging on their demands.

E&C Chair Cathy McMorris Rodgers (R-WA) announced that her committee plans to circulate a drug shortage discussion draft in the coming weeks based learnings from a bicameral request for information (RFI). She notes the RFI received more than one hundred responses and the committees are reviewing them to inform their discussion on drug shortages.

In the Senate, chair of the Health, Education, Labor and Pensions (HELP) Committee Bernie Sanders (I-VT) is refusing to schedule a confirmation hearing for Biden’s nominee for NIH director, Monica Bertagnolli, until the Biden administration promises more drug pricing reform. As STAT reports, he's not the only liberal politician withholding support, as Sen. Elizabeth Warren (D-MA) also wants Bertagnolli to sign a pledge that she won’t join pharmaceutical company boards after her tenure as NIH director.

The White House's Office of National Drug Control Policy (ONDCP) published a National Response Plan to the ongoing crisis of people dying from using xylazine mixed with fentanyl. The plan lists steps and key responsibilities that federal departments and agencies should take and directs them to submit an Implementation Report on how they plan to address the crisis to the White House within 60 days.

Drugs & Biologics

The White House Office of Management and Budget is reviewing a questions and answers guidance from FDA on communications from firms to health care provided regarding scientific information on unapproved uses of certain legally marketed medical products that could be released soon. The guidance does not appear on the Center for Drug Evaluation and Research’s (CDER) guidance agenda, and the agency has struggled in recent years with its approach to enforcing manufacturer communications following several judicial setbacks over the last two decades, including the landmark Caronia, Amarin and Pacira decisions.

The Department of Health and Human Services (HHS) has sent letters to COVID-19 vaccine manufacturers as they prepare to produce updated vaccines for the 2023-2024 COVID-19 vaccination campaign. The department is advising the manufacturers to start planning their updated vaccine supply and regulatory submissions so that FDA and CDC can coordinate with them to make vaccine recommendations by the latter part of September.

The Massachusetts Institute of Technology (MIT) announced it is leading a three-year research program to design the first fully integrated, continuous mRNA manufacturing platform with $82M funding from FDA’s Center for Biologics Evaluation and Research (CBER). The university says the objective is to improve the ability to respond to future pandemics faster as well as develop new treatments for cancers, metabolic disorders, genetic diseases and more.

Health care providers have received a letter from FDA updating them that the agency has reviewed data on paclitaxel-coated devices used to treat peripheral arterial disease (PAD) and has determined that they do not pose increased risk of mortality.

FDA published a draft guidance for Investigational New Drug Application (IND) sponsors and Biologics License Application (BLA) applicants developing cell or gene therapy (CGT) products that addresses product comparability and management of manufacturing changes for investigational and licensed CGT products. The guidance takes a lifecycle approach to CGT products and outlines what regulators are looking for in comparability studies.

Takeda says it has withdrawn a BLA for its dengue vaccine candidate, TAK-003, after talking it over with FDA. The company says there are issues with the data collection that cannot be addressed in the current BLA review cycle, but it plans to keep providing access to the drug in other places while it figures out its next step in the US.

In an FDA podcast with Sarah Ibrahim, the associate director of stakeholder and global engagement at CDER's Office of Generic Drugs talked about the Parallel Scientific Advice (PSA) pilot program that allows applicants to engage FDA and the European Medicines Agency (EMA) concurrently on key issues during the development phase of complex generic drug products and hybrid products.

FDA and the Clinical Trials Transformation Initiative (CTTI) are looking for patient advocate volunteers who want to participate in the Patient Engagement Collaborative (PEC). The collaborative allows FDA staff and patient community representatives to discuss issues related to increasing meaningful patient engagement with diverse populations in medical product development and regulatory discussions at the agency.

The Government Accountability Office (GAO) published a report this week on regenerative medicine, in which the agency says the technology promises to offer patients the ability to restore or replace cell, tissue and organ functions affected by disease, injury or aging. The report also discusses challenges for regenerative medicines and lists policies that may help mitigate them.

Medtech

FDA has scheduled a two-day meeting of its Pediatric Advisory Committee in September to discuss development plans for establishing safety and effectiveness of artificial womb technology devices, including regulatory and ethical considerations for first in human studies. The agency notes that at least one portion of the meeting will be closed to the public.

Boston Scientific says it has gotten FDA approval for the latest iteration of its Vercise Neural Navigator software, which is meant to be used alongside its Vercise deep brain stimulation devices for Parkinson’s and essential tremor. The software is used to program the deep brain stimulation system, and physicians can use it to configure the devices’ leads, and test and set their stimulation settings.

Center for Devices and Radiological Health (CDRH) announced a number of recalls this week including for NOxBOXi's NOxBOXi Nitric Oxide Delivery System (NOxBOXi), Draeger Medical's Oxylog 3000 Plus Emergency and Transport Ventilator, and Megadyne's MEGA 2000 and MEGA SOFT Reusable Patient Return Electrodes.

This Week at FDA: First OTC birth control pill approved, lawmakers advance PAHPA, and more

Related topics

Recommended content

Welcome to the new RAPS Digital Experience