In this week’s news, US FDA overseas inspections mulled, EC wants feedback on devices plan, industry concerned over recall rule changes and more…
Politicians quiz US FDA on overseas inspections
Politicians have questioned the efficacy of US FDA inspections overseas citing the nationwide recall of blood pressure pills as a major concern.
The House Energy & Commerce (E&C) Committee wrote to acting FDA Commissioner Ned Sharpless last week, stating “FDA’s oversight of medical products manufactured overseas remains on GAO’s [Government Accountability Office] most recent high risk list.”
The committee called for data from all overseas inspections, details of how the agency classifies findings as well as un-redacted 483s.
It also told the FDA to provide details of inspections of facilities operated Zhejing Huahai Pharmaceutical (ZHP), which is one of several API firms linked to an ongoing recall of blood pressure medications in the US.
US FDA calls for feedback on clinical summary pilot
In other news, the FDA has asked for feedback on its clinical data summary report pilot programme for new NDAs and BLA.
The agency shared details of its plan to modernise drug review processes in a notice in the US Federal Register last week.
It asked for comment on “the Clinical Data Summary Report Pilot program as part of the Agency’s continuous assessment of the efficiency and transparency of the clinical data used in the regulatory decision-making process.
The FDA also called for feedback on plans for an integrated review template for new drug marketing applications developed as part of the New Drugs Regulatory Program Modernisation programme.
Germany joins EU-US facility inspection pact
The EMA and US FDA will share data from facility inspections carried out by German regulators under their 2014 mutual recognition deal.
The EMA and FDA added Germany to the list of EU member states included in the scheme last week after formally recognising the country’s inspection practices were consistent with international standards.
The EMA wrote, “The FDA thus confirmed the capability of this additional EU Member State to carry out good manufacturing practice (GMP) inspections at a level equivalent to the US.
“The agreement mutually recognises inspections of manufacturing sites for human medicines conducted in the different territories.”
The mutual recognition scheme is designed to help avoid duplicate inspections, reduce the number of audits manufacturers undergo and help identify problem facilities that serve multiple markets.
Read the full FDA statement here.
EC wants device industry advice on plans for new standards
The European Commission has asked industry for feedback on plans to create standards for medical devices and in-vitro diagnostics.
The EC made the call last week, asking developers to comment on the proposed revision and creation of new standards
Areas set for a revamp include medical device sterilisation, biological evaluation, packaging, aseptic processing, clinical assessment and labelling.
Industry concerns over FDA voluntary recall plans
Groups representing the drug industry are worried about US FDA proposals to change the rules on recalls.
The FDA published the draft guidelines in April, explaining they will improve the efficiency and timeliness of voluntary recalls under 21 CFR Part 7 Subpart C, with recommendations on preparations and procedures.
At the time, FDA Associate Commissioner for Regulatory Affairs Melinda K. Plaisier said the aim was to strengthen the recall process, specifically in relation to record keeping, procedures and training.
Last week the agency published the feedback it received. Most commenters welcomed the efforts but said more information is needed.
For example, Zachary Rothstein, vice president of technology and regulatory affairs at industry group AdvaMed, raised concerns about how the proposed guidelines would fit with existing regulations.
“While we agree that a guidance cannot negate a regulation, it is not clear whether FDA intends the draft guidance to supersede interpretations.”
In its response the International Society for Pharmaceutical Engineering (ISPE) said, “FDA appears to be creating a new term, ‘initiation of a recall’ that is not defined in 21 CFR Part 7, and that may cause confusion because there are many steps that a firm takes after it has decided to conduct a recall.”
Also in the news
Abbvie is poised to buy Allergan for $60bn. Read the Wall Street Journal report here.
Ex FDA Commissioner Dr Scott Gotlieb has joined Pfizer’s executive board. See press release.
Insidehealthpolicy reported the long-awaited signing of the US pandemic preparedness bill.
Industry group Socma announced a revamped website.
STAT looked at suggestions Alzheimer’s disease research has been held back.
Small molecule CDMOs are changing how they approach the market in response to shifting industry demands according to Manufacturing Chemist.
And finally some developments of note in the CDMO space: Cobra Biologics and Symbiosis have teamed to establish a viral vector manufacturing and supply service.
Regis Technologies has expanded its solid state chemistry offering.
Catalent has acquired production and supply sites from vaccine firm Novavax. Read more at FiercePharmaManufacturing.