Congress, Feds, FDA Take Action in Opioid Crisis

The House recently enacted multiple legislative proposals to support treatment of opioid abusers and deter inappropriate drug prescribing and illegal distribution. This bipartisan action sets the stage for similar action by the Senate, as the legislators seek to address the deadly drug epidemic before the November midterm elections. A main objective of these policies is to widen access to medications for addiction treatment and

Jill Wechsler

overdose emergencies, a strategy backed by pharma manufacturers of buprenorphine and newer rescue drugs and opioid disorder therapies. The legislation also encourages prescribing of non-opioid pain therapies, but stops short of mandating prescriber education on pain management-or of regulating drug prices.

Meanwhile, the Justice Department brought charges against dozens of individuals involved in prescribing and distributing opioids and illegal narcotics as part of a massive healthcare fraud enforcement action across the country. Although most of the 600 defendants face charges related to schemes to bilk Medicare, Medicaid and other government health programs of some $2 billion in fraudulent claims, the campaign also targeted opioid-related activities, with more than 70 doctors and other health professionals facing charges related to “fanning the flames of the opioid crisis.”

Shutting down websites 

As part of ongoing FDA efforts to reduce illegal opioid prescribing and distribution, the agency seeks to curb the rise in opioid sales through online pharmacies. In June, FDA sent warning letters to operators of 53 websites to halt illegal sales of unapproved, misbranded, and dangerous medicines such as Tramadol and oxycodone, or face product seizures or injunctions. 

FDA also hosted an “opioids summit” to discuss with leading internet operators and other stakeholders ways to reduce the availability of opioids through misleading websites and search engines. The agency cited a January 2018 report from the Senate Permanent Subcommittee on Investigation indicating that online illicit drug sales reached more than $150 million in 2015, as use of the internet to purchase opioids from online pharmacies has soared.

FDA invited leading tech companies to the summit, such as Facebook, Google, Microsoft and Yahoo, as well as online shopping sites, shipping firms, payment processors, and trade associations representing online pharmacies and internet operators. While the tech community maintains that online sales account for only a small portion of illegal drug transactions, FDA Commissioner Scott Gottlieb called for concerted action: “We can’t just play whack-a-mole with illegal sites, shutting down URLs only to watch new ones pop up.”

Cutting off the flow of illicit internet traffic in opioids “is critical,” he said, urging attendees to work together to stop the “digital drug dealers.” 

FDA has increased resources to target and take action against illicit internet drug marketers, despite multiple challenges in doing so. For example, progress in educating health professionals on the importance of reducing prescribing of opioids in favor of less addictive pain medicines now is predicted to send even more individuals suffering from opioid addiction to websites and other sources of illegal and potentially unsafe pills. 

Gottlieb acknowledged that the tech firms at the summit have “the expertise to transform this space.” He cited efforts by Google to de-index web pages linked to FDA warning letters, by Microsoft’s Bing to attach pop-up warnings to such illicit websites, and by Facebook to steer parties seeking opioids online to sites with information on addiction treatment. While there are difficulties associated with implementing these and other strategies, Gottlieb urged further collaboration with the internet experts to devise technological solutions and collective approaches for decreasing opioid availability. 

-------

FDA Clears Pathway for Off-Label Economic Communications 

After years of debate and discussion, FDA has finalized a more flexible policy for how biopharmaceutical companies may discuss payments, outcomes, and healthcare economic data with payers, formulary committees, and other audiences with expertise in drug prescribing and coverage. By clarifying a safe harbor for such communications, the policy is expected to encourage sponsors to conduct more studies that assess economic benefits of treatments, such as gains in quality-adjusted life years (QALYs) and reduced hospital stays and other procedures.

The broader expectation is that such studies and communications will provide data that support efforts by marketers to propose  alternative, value-based contracts and reimbursement strategies, with payments based on expected outcomes and health improvements.

The guidance on “Drug and Device Manufacturer Communications with Payers, Formulary  Committees, and Similar Entities,” announced in June, provides advice to marketers through a question-and-answer format that outlines a broad range of effectiveness, safety, and cost-effectiveness information that marketers may provide to entities involved in formulary management and coverage decisions. FDA Commissioner Scott Gottlieb acknowledged in announcing the revised document that any information provided to payers must be truthful and non-misleading and be presented in an “open, responsible” manner, with background and contextual information that supports informed decision-making.

FDA further extends the policy to manufacturers of both drugs and medical devices and permits providing information to payers on unapproved products and unapproved uses of cleared products to support coverage decisions related to new therapies and to additional new uses. The broader aim is to help “sophisticated parties” with expertise in evaluating such data to assess value-based contracts and innovative reimbursement strategies. 

Jill Wechsler is Pharmaceutical Executive’s Washington Correspondent. She can be reached at jillwechsler7@gmail.com