NIH Awards $945M For Research On Treating Chronic Pain, Opioid Addiction
National Institutes of Health Director Francis S. Collins says the grant “represents the urgency of this crisis.” In other news, the inspector general at the Department of Health and Human Services says NIH should set up better vetting processes to guard against foreign influence; the Food and Drug Administration issues guidelines for regulating some digital diagnostic equipment; HHS' new policy for distributing livers for transplants survives one court challenge; and the FDA criticizes a drugmaker for not being more transparent about the side effects of its insomnia pill.
The Washington Post:
NIH Awards Nearly $1 Billion In Research Grants To Battle Addiction, Chronic Pain
The National Institutes of Health awarded nearly $1 billion on Thursday to battle addiction and chronic pain, the largest financial commitment to one program ever by the government’s premier biomedical research center. About 50 million adults suffer from chronic pain, and in 2018 about 10.3 million people aged 12 and older abused opioids, including heroin, NIH said. “We have effective tools, such as medication-assisted treatment, but we still need better ways to treat opioid addiction and manage pain in an effective, personalized way,” Health and Human Services Secretary Alex Azar said in a news release. (Bernstein, 9/26)
CQ:
NIH Could Do More To Address Foreign Threats, Reports Say
The National Institutes of Health should do more to ensure that investigators and grant reviewers aren’t susceptible to foreign influence, according to a trio of reports from the Health and Human Services inspector general released Friday. The inspector general recommended that the NIH enhance its vetting processes for the independent researchers who review grant applications. The agency could also do more to ensure that research institutions comply with requirements to ensure that investigators disclose all of their funding sources. (Siddons, 9/27)
Stat:
FDA Clarifies How It Will Regulate Digital Health, Artificial Intelligence
The Food and Drug Administration has issued new guidelines on how it will regulate mobile health software and products that use artificial intelligence to help doctors decide how to treat patients. The guidelines, contained in a pair of documents released Thursday morning, clarify the agency’s intent to focus its oversight powers on AI decision-support products that are meant to guide treatment of serious or critical conditions, but whose rationale cannot be independently evaluated by doctors. (Ross, 9/26)
Modern Healthcare:
HHS Liver Allocation Policy Survives Appeal Challenge
A federal appeals court late Wednesday ruled that HHS properly handled the recent overhaul of the nation's system for distributing livers to transplant candidates, but stopped short of upholding the changes. Three judges on the U.S. Court of Appeals for the 11th Circuit determined that HHS did't need to follow a public notice-and-comment process to alter its liver transplant allocation policy. But a federal district court will need to determine whether the changes affect hospitals' due process rights and other legal standards. (Luthi, 9/26)
Stat:
FDA Slams Drug Maker For Not Telling Docs Its Sleeping Pill Is A Controlled Substance
At a time of heightened concern over abuse and dependence issues surrounding medicines, the Food and Drug Administration slammed a small drug maker for sending an email to physicians that appeared to “intentionally” omit any mention that its insomnia pill is a controlled substance. In a Sept. 13 warning letter sent to Galt Pharmaceuticals, the agency complained to the company that the email made numerous claims about the benefits of its Doral pill for treating insomnia. But the email completely failed to mention the warning and precaution language in the prescribing label about the withdrawal syndrome associated with benzodiazepines, such as Doral. (Silverman, 9/26)
