The U.S. Departments of Energy (DOE), Health and Human Services (HHS) and Veterans Affairs (VA) July 28 announced the formation of the COVID-19 Insights Partnership to coordinate and share health data, research and expertise to aid in the fight against COVID-19. The partnership creates a framework for HHS and VA to use DOE’s Summit, the U.S.’ fastest supercomputer, and artificial intelligence resources to conduct COVID-19 research and conduct large-scale, complex analyses on a vast amount of health data. The research and analyses will focus on vaccine and therapeutic development, and outcomes, virology and other critical scientific topics to fill in the gaps on understanding COVID-19.
The FDA issued a draft guidance on setting endotoxin limits during development of oncology drugs administered parenterally, except for intraocular administration, to treat serious and life-threatening cancers based on histology or stage of disease. The draft looks at a risk-based approach of weighing the potential risks of not evaluating endotoxin levels in all components of a multidrug regimen against the potential benefits to patients. Comments on the guidance should be submitted to Docket No. FDA-2020-D-1294 by Sept. 27, 2020.
The FDA Monday reported a shortage of two dosage forms of Abbvie Inc.’s Humira (adalimumab). The shortages are due to the company’s decision to discontinue manufacturing of the 10-mg/0.2 mL and 20-mg/0.4 mL prefilled syringes based on a market assessment and product demand. Abbvie, of North Chicago, will continue to market Humira in the 40-mg/0.8 mL syringes and vials, but the smaller dosages may not be available until biosimilar injectables enter the market in 2023. If the smaller doses are no longer in demand, Abbvie’s decision could make some of the biosimilar companies rethink their marketing plans. The FDA has approved six adalimumab biosimilars, but only two have multiple doses approved. Pfizer Inc.’s Abrilada has been approved in 10-mg/0.2 mL, 20-mg/0.4 mL and 40-mg/0.8 mL injections, and Amgen Inc.’s Amjevita has a 20-mg/0.4 mL and a 40-mg/0.8 mL injection approved. The only dosage approved for Mylan NV’s Hulio is a 20-mg/0.4 mL injection. The other three biosimilars are approved as 40-mg/0.8 mL injections.
The U.S. Medicare Payment Advisory Commission (MedPAC) said in its annual data book on health care spending that enrollment in Medicare is expected to rise steadily throughout most of the 21st century to more than 109 million by 2090. Enrollment in 2060, when most of the baby boom generation will have expired or reached 100 years of age, will amount to roughly 90 million. Total Medicare spending in 2010 was $517 billion, a figure that spiked to $787 billion in 2019, although the share of hospital inpatient spending dropped from 26% in 2010 to 19% in 2019. Total health care spending reached 17.7% of gross domestic product (GDP) in 2018, while Medicare expenditures are expected to account for 6.5% of GDP by 2075. Total Medicare spending over the next decade is expected to grow at an average annual clip of 7%, substantially more quickly than GDP growth, which is expected to average 4% over that same time. Medicare spending is expected to exceed $1 trillion by 2022, and the commission said general revenues from the Treasury have already eclipsed Medicare payroll taxes, Medicare insurance premiums and other sources as the primary source of Medicare funding.
The U.S. Nuclear Regulatory Commission’s (NRC) Advisory Committee on the Medical Uses of Isotopes will hold a virtual meeting Sept. 21-22, 2020, to review medical and nonmedical events from fiscal 2019 and discuss the FDA’s regulatory process for drugs and devices. The NRC also will provide updates on its guidance pertaining to the release of patients administered radioactive material and the activities of its Medical Radiation Safety Team, according to a notice published in Tuesday’s Federal Register.
Although the U.S. House of Representatives passed a package of four spending bills Friday, including one that would fund the FDA for fiscal 2021 and provide an additional $995 million to respond to the COVID-19 pandemic, the heightened partisanship of an election year makes it unlikely that any appropriations bill will be signed into law prior to the November elections. If that happens, a continuing resolution would be needed to keep the federal government running after Sept. 30. Friday’s 224-189 party-line vote in the House came despite a 13-page veto threat the White House had issued the day before.
Taro Pharmaceuticals USA Inc., a wholly owned subsidiary of Hawthorne, N.Y.-based Taro Pharmaceutical Industries Ltd., last week entered a deferred prosecution agreement with the U.S. Department of Justice (DoJ) to resolve two felony charges involving two separate conspiracies to fix prices and rig bids for generic drugs. The company agreed to pay a fine of nearly $205.7 million and to cooperate with DoJ in its ongoing investigation of generic drug price fixing. As part of the agreement, Taro admitted to participating in a conspiracy from March 2013 through December 2015 with Sandoz Inc.; Ara Aprahamian, a former Taro vice president of sales and marketing; and other individuals. It also admitted to a second conspiracy, in the same timeframe, with an undisclosed generic drug company in Pennsylvania and other individuals. Both conspiracies allegedly involved price fixing, allocating customers and rigging bids for numerous generics, including drugs to treat seizures, bipolar disorder, pain, arthritis and various skin conditions. To date, the DoJ investigation has resulted in charges being filed against six generics companies and four executives, including Aprahamian who was indicted in February and is awaiting trial. Along with Taro, Sandoz and three other companies have entered deferred prosecution agreements, according to DoJ.
Indivior Solutions last week pleaded guilty to one felony count related to the marketing of opioid addiction treatment, Suboxone, (buprenorphine), and together with its parent company, Indivior plc, of Slough, U.K., agreed to pay a total of $600 million to resolve criminal and civil liability, according to DoJ. As part of its guilty plea, Indivior admitted to making false statements to the Massachusetts Medicaid program about the safety of Suboxone Film around children. The criminal plea agreement includes $289 million in fines, restitution and interest and requires Indivior to permanently disband its Suboxone sales force; prohibits the company from using data from health care provider surveys for marketing, sales and promotional purposes; and requires it to remove doctors at high risk of inappropriate prescribing from its promotional programs. The $300 million civil settlement, which includes a corporate integrity agreement, resolves claims in six whistleblower suits alleging that Indivior knowingly promoted the sale and use of Suboxone to doctors who were writing inappropriate prescriptions, made false and misleading claims about the safety of the drug in promoting its use, and took steps, including a citizen petition to the FDA, to delay generic competition. In a separate $10 million consent decree with the Federal Trade Commission (FTC), Indivior committed to notifying the FTC if it filed a citizen petition related to a drug and to provide both the commission and the FDA with all studies and data related to the petition. It also agreed not to remove a drug from the market or disadvantage a product after gaining approval for a new drug with the same active pharmaceutical ingredient. The agreements follow a plea agreement last month with former Indivior CEO Shaun Thaxter. Together with a $1.4 billion agreement reached last year with Indivior’s former parent, Reckitt Benckiser Group plc, the new agreements bring the total resolution of charges related to Suboxone marketing to more than $2 billion, according to DoJ. That’s the largest resolution in a case brought by DoJ involving an opioid.
The Association for Accessible Medicines (AAM) lacks standing to pursue a preliminary injunction against enforcement of a new California law banning pay-for-delay patent settlements between brand and generic drug companies, the U.S. Court of Appeals for the Ninth Circuit determined last week in an unpublished opinion. The trade association failed to show a substantial risk that the new law “will cause any of its members to suffer injury that is concrete, particularized and imminent,” the court said. It noted that AAM’s members said they are engaged in patent-infringement lawsuits and that they historically have settled such lawsuits, but they didn’t allege that they intend to enter into settlement agreements that would be prohibited by the California law. The court also found that AAM’s members have not yet suffered economic harm because of the law. Instead, the court said, the generic drug companies claimed “they ‘likely would expect to be forced to litigate every pending patent-infringement lawsuit to judgment,’ or that they ‘likely will stay [their] hand on many products and simply stay off the market until the relevant patents all expire.’” The court added, “These declarations allege only ‘possible future injury’ and do not establish a substantial risk of harm.”