Congressional Action Alters FDA Policies, Pharma Practices

Before leaving Washington to campaign for the November mid-term elections, members of Congress approved a few bills with provisions important to FDA and industry. Some measures-as well as industry-backed bills that fell by the wayside-reflect continuing concerns about drug pricing and transparency.

Most prominent is legislation to help fight the deadly opioid epidemic, which gained strong bi-partisan support from legislators anxious to impress the voters. This multi-faceted 660-page package authorizes $8.5 billion to support a range of prevention and treatment programs. It increases access to medication-assisted treatment for substance abuse disorders and lifts a decades-old rule that limited Medicaid coverage of residential treatment for such individuals.

One notable measure authorizes FDA to require drug manufacturers to distribute opioids in blister packs with limited three- to seven-day supplies. The bill also aims to combat illegal import and sale of illicit drugs such as fentanyl by authorizing FDA collaboration with other federal agencies to block mail shipments into the United States of violative products. A late tweak retains FDA flexibility to permit individual patients to import drugs for personal use. And the Drug Enforcement Administration can reduce manufacturing quotas for controlled substances, including prescription opioids where there is evidence of diversion.

To support access to non-opioid painkillers, FDA is directed to hold a public meeting and publish guidance on developing non-addictive pain products. The agency will require postmarket studies or clinical trials to assess whether such drugs remain effective pain treatments and will consult with stakeholders on evidence-based opioid prescribing guidelines for physicians treating acute pain.

Important for pharma is a little-noticed provision that expands the scope of the “Sunshine Act” by requiring pharma and medical products makers to report on payments and gifts to additional healthcare practitioners. “Covered recipients” in the Open Payments program now will include physician assistants and a range of nurses, in addition to physicians and teaching hospitals. At the same time, the legislators rejected a big industry push for a change in how they pay for drugs in the Medicare Part D coverage gap. And generic-drug makers lost their bid for reform in how brand-drug companies use FDA-mandated safety programs to block access to brand supplies needed for equivalence testing.

No more “gag clauses”

In the name of drug price transparency, Congress also approved legislation to override rules set by pharmacy benefit managers (PBMs) that prevent pharmacists from informing patients about less costly options for obtaining prescriptions. The measures ban such gag clauses for Medicare drug plans and for commercial insurers.

That legislation also takes action against “pay-for-delay” deals between brand and generic-drug firms by extending disclosure requirements on such agreements to biologics and biosimilars. Manufacturers of conventional drugs already have to report on patent settlements to the Federal Trade Commission, and now that policy applies to biologics.

Congress also approved a massive funding bill that covers the Department of Health and Human Services, with a notable increase in the budget for the National Institutes of Health. But another budget measure that covers FDA was put aside. That bill may move forward in the post-election “lame duck” session, but FDA currently operates under a “continuing resolution” based on last year’s funding.