AUGUST 2018 INDUSTRY NEWS
FDA’s Strategic Policy Roadmap for 2018
“FDA Commissioner Scott Gottlieb, MD laid out an 18-page “roadmap” for achieving the FDA’s 2018 goals and objectives. The broad sweep of initiatives addresses four main objectives: reducing opiod and other addictions, leveraging innovation and competition, empowering consumers and strengthening FDA’s scientific workforce.”
Medical device sector sees most quarterly recalls in over a decade
“The second quarter of 2018 saw the largest number of medical device recalls during a single quarter since at least 2005, according to a recent analysis of U.S. recall data. Each quarter, product recall management company Stericycle Expert Solutions releases a “recall index” detailing the frequency and causes of U.S. product recalls in the food, pharmaceutical, automotive, medical device and consumer product industries. To compile its report on the second quarter of 2018, Stericycle Expert Solutions analyzed data from the Consumer Product Safety Commission, the FDA, the Food Safety and Inspection Service of the U.S. Department of Agriculture and the National Highway Traffic Safety Administration. The firm identified 360 recalls in the medical device sector during the second quarter of 2018, up 5 percent from the first quarter.”
Brexit and the pharmaceutical industry: what happens if there’s no deal?
The pharmaceutical industry has voiced its increasing concerns about the possibility of no-deal Brexit when the UK leaves the EU in March next year, and what effect this will have on the industry and the supply of medicines to patients. In response, the UK Government announced a range of advice on batch testing, safety and quality of blood and organ products, as well as the marketing authorisation of drugs and regulation of clinical trials.
Medical Devices and Device-Led Combination Products; Voluntary Malfunction Summary Reporting Program for Manufacturers
“The Food and Drug Administration’s (FDA, Agency, or we) Center for Devices and Radiological Health and Center for Biologics Evaluation and Research are announcing that the Agency is granting an alternative that permits manufacturer reporting of certain device malfunction medical device reports (MDRs) in summary form on a quarterly basis. We refer to this alternative as the “Voluntary Malfunction Summary Reporting Program.” This voluntary program reflects goals for streamlining malfunction reporting outlined in the commitment letter agreed to by FDA and industry and submitted to Congress, as referenced in the Medical Device User Fee Amendments of 2017 (MDUFA IV Commitment Letter).”
JULY 2018 INDUSTRY NEWS
FDA green-lights 14 digital health products, continues to evolve regulations
“…The FDA is turning to developers in the digital health space to help solve some of the country’s most difficult problems. In May, the agency announced an innovation challenge aimed at tackling the opioid epidemic, where developers could share their approaches to detecting, treating, and preventing addiction. The agency is also making some new moves when it comes to regulation. Notably, in June the agency ruled that genetic risk tests are officially exempt from requiring 510(K) premarket approval, provided the company offering the test has gone through a one-time premarket review of its testing apparatus and at least one test.”
High-Risk Medical Device Approval Process in Europe Inches Towards Transparency
“The European Union (EU) is moving ahead with plans to provide better access to data surrounding the approval of implantable and high-risk medical devices, but a group of experts suggest that full transparency with respect to clinical and preclinical data, among other things, is the best path forward. In 2017, a new EU law was introduced that will eventually require manufacturers to provide a summary of the safety and clinical performance (SSCP) of high-risk medical devices. Prior to the regulation, the details of which are still being ironed out, the information that led to the approval of implantable, high-risk medical devices—drug-eluting stents, prosthetic heart valves, pacemakers, and the like—was confidential. Indeed, the first news a physician might hear about a new device was that it had been approved for use.”
CDER announces sweeping structural changes in letter from Woodcock to staff
Janet Woodcock, director of the Food and Drug Administration’s Center for Drug Evaluation and Research, announced in-depth changes to the structure of the office this week in a note to staff. The changes will affect the Office of New Drugs, Office of Compliance, Office of Executive Programs, and Office of Communications. The aim of the changes, which are pending approval from the Department of Health and Human Services, and submission to Congress for concurrence, are “aimed at modernizing and strengthening the way FDA fulfills its public health and regulatory role,” according to Woodcock.
UK Votes to Stay in EMA
“The UK Parliament on Tuesday voted 305-301 in favor of continuing the UK’s involvement with the European Medicines Agency (EMA) after the island leaves the EU. The vote means Parliament will make it a negotiating objective for the UK government to seek the UK’s participation in the European medicines regulatory network, according to the UK BioIndustry Association (BIA). In a joint statement on behalf of the pharmaceutical industry in the UK, Mike Thompson, chief executive of the Association of the British Pharmaceutical Industry, and Steve Bates, chief executive of the BioIndustry Association, said: “Parliament has sent a clear message that patients and public health should be a top priority for the Government in these negotiations. Every month, 37 million packs of medicine arrive in the UK from the EU and 45 million move the other way. Therefore, it is essential that the UK continues to participate in the EMA after Brexit, as set out in the Brexit White Paper and in the Prime Minister’s Mansion House speech.”
JUNE 2018 INDUSTRY NEWS
FDA’s New Efforts to Advance Biotechnology Innovation
“FDA is committed to helping ensure the safety of biotechnology products, while also facilitating innovation by applying a risk-based regulatory approach that provides developers with regulatory clarity and predictability and maintains public confidence in our regulatory system. And we’re taking some new steps to advance these goals. We know that products enabled by new techniques of biotechnology have the potential to significantly enhance public health.”
FDA Set to Propose Adoption of ISO 13485 for Quality Systems
“In an effort to harmonize its medical device quality management system regulations with globally-accepted standards, the U.S. Food and Drug Administration (FDA) is reportedly set to propose the adoption of ISO 13485:2016 as a replacement for its current Quality System Regulations (QSRs)…. “The proposed change is part of the federal government’s Spring 2018 “Unified Agenda of Federal Regulatory and Deregulatory Actions,” and reflects efforts by the FDA to make it easier and more efficient for medical device manufacturers to sell their products outside of the U.S. while continuing to maintain high quality standards.”
Guidance for Pharmaceutical Companies to Prepare for UKs Withdrawal from EU
“The European Medicines Agency (EMA) and the European Commission have updated their guidance to help pharmaceutical companies prepare for the United Kingdom’s (UK) withdrawal from the European Union (EU). Updates to the questions-and-answers document are marked ‘NEW’ and include information on how the UK’s withdrawal will affect the status of inspection outcomes by the UK national competent authority and batch release processes for medicines that are subject to Official Control Authority Batch Release (OCABR) and Official Batch Protocol Review (OBPR).”
FDA To Issue Guidance on Cell and Gene Therapy in July
“Scott Gottlieb has kept himself busy during his tenure as head of the Food and Drug Administration. And the agency chief made clear in a fireside chat at the BIO International convention that the FDA has plenty coming down the pike in the months ahead — particularly in the areas of cell and gene therapy. Gottlieb pointed to the hundreds of Investigational New Drug applications currently in place for cell and gene therapies, citing one study that suggests as many as 40 of these drugs could be approved over the next few years.
FDA Withdraws Guidance on Biosimilar Analytical Studies
“In response to industry concerns, the US Food and Drug Administration (FDA) on Thursday announced it has withdrawn its draft guidance on evaluating studies used to demonstrate analytical similarity between a biosimilar and reference biologic. FDA says it plans to reissue the draft guidance after considering changes to the document that will “promote a more efficient pathway for the development of biosimilar products…To date, FDA has approved 11 biosimilars to eight reference biologics since approving its first biosimilar in 2015. However, only a fraction of those biosimilars are available on the market, with legal challenges often adding years between approval and commercial launch.”