A lower court got it right last year when it struck down a Health and Human Services (HHS) rule requiring TV ads for prescription drugs covered by Medicare or Medicaid to include list prices, the U.S. Court of Appeals for the District of Columbia Circuit said Tuesday in a unanimous opinion in Merck & Co. Inc. v. the U.S. Department of Health and Human Services. Noting that the price the rule required drug companies to disclose “bears little resemblance to the price beneficiaries actually pay under the Medicare and Medicaid programs,” the appellate court said HHS “acted unreasonably in construing its regulatory authority to include the imposition of a sweeping disclosure requirement that is largely untethered to the actual administration of the Medicare or Medicaid programs.” The court also found “no reasoned statutory basis” for the rule’s “far-flung reach and misaligned obligations.” When Merck, Eli Lilly and Co., Amgen Inc. and the Association of National Advertisers Inc. challenged the rule last year, they claimed it violated the Administrative Procedure Act (APA) in that it exceeded HHS’ authority and that it also violated the First Amendment. Both the lower and appellate courts declined to take up the First Amendment challenge, instead striking the rule down on the strength of the APA argument. Absent an appeal to the Supreme Court, Tuesday’s ruling would close the door on future administration efforts to force public disclosure of drug prices. However, Congress could carry through on threats to do so legislatively, in which case the First Amendment argument likely would be raised again.
Warning: some regulatory websites are being targeted by hackers and scammers. Japan’s Pharmaceutical and Medical Devices Agency (PMDA) has put a warning on its website telling users that fake PMDA websites have been found recently. “These websites may steal your information or money or cause any other types of loss or damages,” the PMDA cautioned. The agency also noted that it is receiving many inquiries regarding the licensing and registration of personal protective equipment (PPE) such as surgical masks and N95 respirators for importation, manufacturing and marketing in Japan. The PMDA said it doesn’t issue licenses or certificates for PPE. The website for India’s Central Drugs Standard Control Organisation also appeared to be vulnerable this week, as attempts to access it were met with warnings about attackers potentially stealing information from cdsco.gov.in.
After announcing Monday that it was revoking the emergency use authorization (EUA) for oral formulations of chloroquine phosphate and hydroxychloroquine sulfate in treating COVID-19, the FDA warned about a newly discovered potential drug interaction when the malaria drugs are used with Gilead Sciences Inc.’s remdesivir, an investigational antiviral that has received an EUA for the treatment of hospitalized COVID-19 patients with severe disease. Based on a recently completed nonclinical laboratory study, the FDA said it is revising its fact sheet for health care providers to recommend against co-administration of the drugs as it may result in reduced antiviral activity of remdesivir.
The U.K.’s Medicines and Healthcare products Regulatory Agency (MHRA) Tuesday instructed sponsors of clinical trials evaluating hydroxychloroquine to treat or prevent COVID-19 to suspend recruitment. No new participants can be recruited to the trials until further data justifying their continuation has been provided and additional safety measures have been implemented, the MHRA said. The decision follows a review of the results from two different trials, including the U.K.’s Recovery trial, “which has provided convincing evidence of no meaningful mortality benefit in hospitalized patients with COVID-19,” according to the agency.
The U.S. Patent and Trademark Office (USPTO) launched a new program this week to advance the initial examination of applications for trademarks and service marks used to identify qualifying COVID-19 medical products and services. The program is open to applications for products subject to FDA approval for use in the prevention or treatment of COVID-19 or a medical or medical research service to prevent or treat the coronavirus infections. In addition to expediting the examination, the USPTO will waive the fee for the petitions. “Inventors and entrepreneurs are working around the clock to develop products that will help prevent, diagnose, treat or cure COVID-19,” USPTO Director Andrei Iancu said. “Accelerating initial examination of COVID-19-related trademark applications for these products … will help to bring important and possibly life-saving treatments to market more quickly.”
More than a year after the U.S. Court of Appeals for the Federal Circuit reversed a lower court’s grant of summary judgment in Supernus Pharmaceuticals Inc. v. Iancu, the USPTO is revising the rules of how it determines patent term adjustments in keeping with that precedential ruling. In calculating the adjustment, the USPTO cannot "count as applicant delay a period of time during which there was no action that the applicant could take to conclude prosecution of the patent," the Federal Circuit said in the January 2019 decision involving a Supernus osmotic drug delivery system patent licensed exclusively to United Therapeutics Corp., of Silver Spring, Md. When determining the patent term adjustment, the USPTO had reduced the adjustment by 646 days due to applicant delay, even though there was nothing Supernus could have done during the 546 days between the filing of its request for continued examination/original information disclosure statement in 2011 and its submission of a European Patent Office notice of opposition, which it didn't receive until 2012. The USPTO’s new final rule will go into effect July 16, according to a notice published in Tuesday’s Federal Register.
The MHRA issued a guidance Monday on how it involves the public in its regulatory decision-making. The guidance is part of the agency’s commitment to “delivering a step-change in the way we engage with patients and the public, putting their views and interests at the heart of our decision-making and culture,” the MHRA said. The goal is to adopt a more transparent, responsive and systematic approach to listening to and involving patients and the public.
The FDA finalized its 2018 guidance, "Patient-focused drug development: collecting comprehensive and representative input.” It is the first in a series of four guidances intended to facilitate the advancement and use of systematic approaches to collect and use robust and meaningful patient and caregiver input that can more consistently inform the development of medical products and regulatory decision-making. The first guidance presents methods for collecting information on the patient experience that’s representative of the intended population to inform the development and evaluation of medical products throughout the product’s lifecycle. It also discusses methods to operationalize and standardize the collection, analysis and dissemination of patient experience data and includes a glossary of terms that will be used in subsequent guidances in the series.
“Unless substantial changes are made to the way Medicare pays for services and to how beneficiary care is organized and delivered, the cost of the Medicare program will remain on an unsustainable trajectory,” the Medicare Payment Advisory Commission warned this week in its June 2020 report to Congress on Medicare and the health care delivery system. The report urges that serious attention be given to new innovations that would change how hospitals are paid and give providers incentives to manage drug costs. The report also asserts that fee-for-service payment for Medicare services should be replaced by payment to accountable systems of care that have incentives to provide preventive services and early disease detection, avoid delivering unnecessary or inappropriate services, and enhance the use of technologies that improve quality and reduce costs.
The Institute for Clinical and Economic Review (ICER) is assessing the comparative clinical effectiveness and value of Novartis AG’s inclisiran and Esperion Therapeutics Inc.’s Nexletol (bempedoic acid) as treatments for heterozygous familial hypercholesterolemia or secondary prevention of atherosclerotic cardiovascular disease. Inclisiran is currently undergoing FDA review, with an anticipated decision expected at the end of the year, according to ICER. Nexletol received FDA approval Feb. 21, 2020. Comments should be submitted by June 30. ICER’s timeframe for the assessment includes releasing a draft scoping document July 6, followed by a review of the evidence report during a public meeting of the Midwest Comparative Effectiveness Public Advisory Council in February 2021.
Three Republican U.S. senators have unveiled a companion bill to the Bring Entrepreneurial Advancements to Consumers Here In North America (BEAT CHINA) Act, part of a legislative program intended to prompt pharmaceutical and medical device companies and their suppliers to relocate to the U.S. The legislation would amend the tax code to provide those incentives, including a provision that would allow bonus commercial real estate property to be fully deductible at a year for companies that relocated to the U.S. from another nation. Companies would not incur a U.S. tax liability for the sale of assets located in other nations, although the domestic production volumes would have to match the company’s production in the dismantled foreign location. Bill co-sponsor Kelly Loeffler (R-Ga.) said the COVID-19 pandemic "has shown us just how dangerous it is to rely so heavily on other countries, including China, for critical, life-saving products like drugs and medical devices as well as supplies like gowns, masks and swabs. It is time we incentivize companies to bring those factories and jobs back to the United States.”