MARCH 2020 INDUSTRY NEWS
Coronavirus: Carmakers answer pleas to make medical supplies
“On Monday, Fiat began converting one of its car plants in China to start making about one million masks a month. The carmaker wants to start production in the coming weeks, wrote its chief executive Mike Manley in an email. Other major car firms are looking at ways they can shift manufacturing towards ventilators. General Motors, Ford and Tesla in the US have all pledged their support to offer resources to make more ventilators, along with Japanese carmaker Nissan and Formula 1 teams in the UK. Major car plants in the US, Europe and Asia have halted production to try to help prevent the spread of coronavirus. But they are still pledging to help make ventilators and other vital medical equipment.”
GOP lawmaker introduces bill to end dependency on China’s pharmaceutical manufacturing
“In the wake of the coronavirus pandemic and supply chain disruptions, one Republican lawmaker is seeking to decrease America’s dependence on China. Appearing on “Fox and Friends” Sunday, Sen. Marsha Blackburn (R-Tenn.) explained that she has introduced legislation to increase America’s pharmaceutical production to decrease dependency on China. “It is the SAM-C Bill, Securing America’s Medicine Cabinet,” Blackburn said. “Many of the pharmaceuticals that are necessary for creating some of these viruses — and certainly the coronavirus family is one of those — they’re made only in China. We are depended upon them for these. They’re called APIs: active pharmaceutical ingredients,” she continued. “My legislation would incentivize bringing that production back on U.S. shores.”
FDA Continues to Facilitate Access to Crucial Medical Products, Including Ventilators
“Today, the U.S. Food and Drug Administration took significant action to help increase the availability of ventilators and accessories, as well as other respiratory devices, during the COVID-19 pandemic to support patients with respiratory failure or difficulty breathing. “The FDA’s new actions will mean America can make more ventilators during this crisis,” said Health and Human Services Secretary Alex Azar. “Today’s actions are another step by the FDA and HHS to eliminate every possible barrier to the all-of-America approach that President Trump has called for. With this boost from the FDA, medical device makers can more easily make changes to existing products, such as changes to suppliers or materials, to help address current manufacturing limitations or supply shortages. Other manufacturers, such as auto makers, can more easily repurpose production lines to help increase supply. Hospitals and other health care providers can repurpose machines they have now to serve as ventilators. HHS and FDA’s message is clear: If you want to help expand production of ventilators to save American lives in this pandemic, we are going to work with you to sweep every possible barrier out of your way.”
FDA now allows treatment of life-threatening COVID-19 cases using blood from patients who have recovered
“The U.S. Food and Drug Administration (FDA) has updated its rules around use of experimental treatments for the ongoing COVID-19 pandemic to include use of “convalescent plasma,” in cases where the patient’s life is seriously or immediately threatened. This isn’t an approval of the procedure as a certified treatment, but rather an emergency clearance that applies only on a case-by-case basis, and only in extreme cases, as a means of helping further research being done into the possible efficacy of plasma collected from patients who have already contracted, and subsequently recovered from, a case of COVID-19. Plasma is a component of human blood — specifically the liquid part — which contains, among other things, antibodies that contribute to a body’s immune response. Use of plasma, through direct transfusion into a patient, like every other proposed treatment for COVID-19 (and the SARS-CoV-2 virus that causes it), has not undergone the clinical studies needed to show that it’s actually safe and effective in combating the disease.”
FEBRUARY 2020 INDUSTRY NEWS
FDA, expecting a gene therapy boom, firms up policies
“FDA approvals for Roche’s blindness therapy and Novartis’ muscular atrophy treatment were landmark moments for the gene therapy field, showing what’s possible through gene-based medicine. The next several years look set to feature many more milestones, with nearly 1,000 gene therapy studies currently underway and some half dozen treatments advancing quickly toward regulatory review. “These therapies, once only conceptual, are rapidly becoming a therapeutic reality,” FDA Commissioner Stephen Hahn, who was sworn in as agency chief last month, said in a statement.”
“The countdown is on for medical device manufacturers to prepare for the EU Regulation on Medical Devices (MDR), which will fully apply in member states from May this year. But in a recently published paper, trade association MedTech Europe raised concerns that the new regulatory system is not ready to support the transition of technology from the old regime. The new EU MDR came into force on May 5, 2017, replacing two existing directives, and applies after a transitional period of three years, which falls on May 26, 2020. Under the MDR, manufacturers have clearer obligations to monitor the quality, performance and safety of devices. Also, existing devices which have been CE marked under the current EU Medical Device Directive (MDD) must be recertified to abide by the new MDR. MedTech Europe says that manufacturers may not be able to keep existing devices on the market, because of challenges such as a lack of notified body (NB) capacity, lack of EU guidance on certain aspects of the regulation, and lack of expert panels.”
“Just two weeks after Brexit, the UK government has introduced a bill to update its regulatory framework for human and veterinary medicines, clinical trials and medical devices, while ensuring the UK remains an attractive market for the life sciences industry. The bill was read for the first time in the House of Commons on Thursday and is scheduled for a second reading on 2 March. The UK is currently in the midst of an 11-month transition period ending 31 December 2020, during which it will continue to follow EU law. Once the transition period ends, the UK will no longer be able to update its regulatory schemes for healthcare products and clinical trials through secondary legislation under section 2(2) of the European Communities Act (ECA) or via section 11 of the Consumer Protection Act (CPA) for certain aspects of medical device regulation.”
FDA Gets Ready for Changes to Biologics Regulation
Drug companies will have more clarity over how the FDA regulates their products following an agency rule revising the definition of certain complex and expensive drugs. The Food and Drug Administration, in a rule set to publish Friday in the Federal Register, squares its regulatory definition for those drugs, called biologics, with the definition Congress agreed to in a spending deal in December 2019. The rule is aimed at setting the framework for a new requirement, set to take effect March 23, under which companies seeking to bring certain drug products to market will have to submit an application for a biologic instead of for a simpler drug. The rule also will take effect March 23. The upcoming change reflects the agency’s effort to remove regulatory hurdles to creating cheaper versions of insulin and other drugs. Insulin is one of about 90 products that will shift to the biologics system in March.
JANUARY 2020 INDUSTRY NEWS
EMA and its European and international partners are launching a pilot programme to increase their cooperation in the inspection of manufacturers of sterile medicines for human use. This new initiative is built on the success of and experience gained from a similar collaboration, the international active pharmaceutical ingredients (APIs) inspection programme. This collaboration will allow EMA, EU national authorities (France and the United Kingdom), the United States Food and Drug Administration (FDA), Australia’s Therapeutic Goods Administration (TGA), Health Canada, the Japanese Pharmaceuticals and Medical Devices Agency (PMDA), and the World Health Organization (WHO) to share information on Good Manufacturing Practice (GMP) inspections of manufacturers of sterile medicines who are located outside the participating countries, and to organise joint inspections for manufacturing sites of common interest.
The FDA actions that dominated 2019 demonstrated a shifting regulatory landscape for certain product types, such as e-cigarettes, foods and supplements containing cannabidiol (CBD), and digital health / machine learning enabled medical devices. FDA continued to take action to lower drug prices by focusing on approvals of competitive biosimilars and generic drugs, and FDA enforcement actions signaled the Agency’s ongoing interest in ensuring GMP compliance overseas.
FDA Updates Compliance Guide on Pre-approval Inspections for Drugs
“Drug manufacturers looking to avoid Form 483s take note: the US Food and Drug Administration (FDA) has recently tweaked its compliance guide on pre-approval inspections, which according to one consultant will impact analytical procedures and data included in regulatory submissions. A pre-approval inspection is performed by FDA to ensure that a manufacturing establishment named in a drug application is capable of manufacturing a drug, and that submitted data are accurate and complete. The front of the updated compliance guide, which was first released in September but which will not fully take effect until 16 September 2022, explains the changes: “Revision: Program revised to add instructions for potential official action indicated (pOAI) reporting responsibilities and to align with the Center for Drug Evaluation and Research (CDER) and Office of Regulatory Affairs (ORA) agreement Integration of FDA Facility Evaluation and Inspection Program for Human Drugs: A Concept of Operations.”
5 trends to watch at the FDA in 2020
“The Food and Drug Administration is one of America’s most closely scrutinized agencies, tasked as it is with guaranteeing the safety of both food and medicine. The political winds have demanded the FDA not erect too many barriers to the approval of new drugs, particularly those treating orphan diseases and terminal illnesses, and the agency’s response has been impressive.“
DECEMBER 2019 INDUSTRY NEWS
The IMDRF Cybersecurity Guidance: A Comprehensive Analysis
“Currently, cybersecurity guidelines for medical devices vary from country to country. In the United States, the U.S. Food and Drug Administration (FDA) has released two guidance documents aimed primarily at medical device manufacturers. Content for Premarket Submissions for Management of Cybersecurity in Medical Devices and Postmarket Management of Cybersecurity in Medical Devices — issued in 2014 (updated in 2018) and 2016, respectively — provide important information about what the FDA expects relevant to cybersecurity in premarket submissions and in postmarket management plans. These guidance documents have become the basis for regulatory guidance in several other countries. However, many countries have developed different guidelines or have not issued any guidance at all, creating significant confusion in the marketplace.“
Senate confirms Dr. Stephen Hahn as FDA commissioner
“The US Senate on Thursday confirmed Dr. Stephen Hahn to be the next commissioner of the US Food and Drug Administration. The Senate vote was 72 to 18. Hahn, 59, is a well-known radiation oncology expert and is the current chief medical executive of The University of Texas MD Anderson Cancer Center in Houston, where has been a professor of radiation oncology since January 2015. “Dr. Hahn can now get to work approving new life-saving drugs and devices, regulating tobacco and e-cigarettes, addressing the opioid crisis, ensuring pain patients can receive the medications they need and protecting our nation’s food supply,” Republican Sen. Lamar Alexander wrote in a Twitter post following the confirmation.”
Medical Device Tax Is History After Trump Signs Repeal
“The medical device industry hailed President Trump’s signing into law a bipartisan federal spending package that brings in an end to a tax the medical technology industry has been fighting against for the last decade. The 2.3% tax on medical device sales that is part of the Affordable Care Act has already been on temporary hiatus since the beginning of 2016, but was scheduled to return at the end of this year if Congress didn’t eliminate the tax or put it on hiatus once again. Medical device makers feared a major hit to their bottom lines, research budgets and jobs if Congress didn’t end or at least shelve the tax before the end of the year. A report released earlier this month from the Tax Foundation shows a return of the medical device tax would “would result in a decline of 21,390 full-time equivalent jobs and a reduction in GDP of $1.7 billion.”
NOVEMBER 2019 INDUSTRY NEWS
Best Practices in Drug and Biological Product Postmarket Safety Surveillance for FDA Staff: Draft Guidance
“Comments and suggestions regarding this draft document should be submitted within 60 days of publication in the Federal Register of the notice announcing the availability of the draft document. Submit electronic comments to https://www.regulations.gov. This document, 1 55 Best Practices in Drug and Biological Product Postmarket Safety Surveillance for FDA 56 Staff, sets forth risk-based principles by which the Food and Drug Administration (FDA or Agency) 57 conducts ongoing postmarketing safety surveillance for human drug and biological products (biologics).”
ICH Survey Shows Wide Adoption of Guidelines Among Regulators, Industry
“A recently released survey from the International Council on Harmonisation (ICH) shows pharmaceutical regulators and companies around the world are adopting and adhering to the council’s guidelines related to quality, safety and efficacy.
The survey of 32 pharmaceutical companies provided responses on 15 regulatory authorities, which included the founding ICH members: the European Medicines Agency, the US Food and Drug Administration, Japan’s MHLW/PMDA, Health Canada and Swissmedic, as well as other newcomers from Brazil, China, Singapore and South Korea, and observers from Malaysia, Russia, South Africa and Turkey.”
How software may be classified under medical device regulation guidance
“The new regulatory landscape on software medical devices that will apply under the new Regulations (Regulation (EU) 2017/745 (Medical Device Regulation (MDR)) and Regulation (EU) 2017/756 (In Vitro Diagnostic Regulation (IVDR)) as of 26 May 2020 and 26 May 2022 respectively, has been somewhat clarified by new guidance published by the European Commission’s Medical Devices Coordination Group (MDCG). Given that the Guidance has been the result of considerable work/ deliberations by the MDCG, due to the particularities of and fast pace of innovation in software as a medical device, one would expect more topics to have been addressed and perhaps in more depth. Still, this Guidance provides the first valuable insight into how software will be classified under the new Regulations, while more specific examples will continue to be included in the Borderline manual guidance.”
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