Gottlieb Encourages Biosimilars and Safer Opioid Packaging

In highlighting key FDA priorities for the coming months, commissioner Scott Gottlieb told agency advocates in Washington DC that he will continue to seek ways to curb rampant opioid addiction, to promote competition that curbs high drug prices, and to advise on right-to-try legislation that helps patients. An ongoing challenge is to maintain resources across all FDA operations in an “austere budget environment,” particularly for those programs without support from user fees.

More access to biosimilars is key to bringing down outlays on prescription drugs, and FDA is preparing a “comprehensive plan” to bolster the market for these products, Gottlieb said at a briefing held during the first week of February 2018 in Washington, DC sponsored by the Alliance for a Stronger FDA and the Pew Charitable Trusts. He urged health plans, payers, and supply chain entities to support biosimilar coverage and reimbursement, as opposed to established products offering rebates designed to discourage biosimilar reimbursement. FDA also will propose regulatory action to facilitate approval of interchangeability claims for the new alternative therapies.

The commissioner reiterated the need for brand manufacturers to stop “gaming” the system by denying access to products needed for bioequivalence testing of generics. FDA is looking for ways to modernize the interpretation of the Hatch-Waxman Act, Gottlieb added, particularly related to combination products where the drug component is off-patent, but the delivery device is not. Market competition also may gain from more ready access to over-the-counter medicines through legislation that modernizes the regulatory framework for these products. And FDA is looking at how medical apps may help individuals select the appropriate over-the-counter (OTC) medicine in the pharmacy based on, say, cholesterol levels or blood pressure.

Safer opioid packaging

A continuing priority for FDA is to reduce the prescribing and distribution of opioids to curb inappropriate use. Now the agency is encouraging new drug packaging methods to reduce opioid exposure in the medical system. FDA recently called on manufacturers of the diarrhea drug loperamide, marketed OTC as Imodium and store brands, to discontinue distribution of large-volume bottles and adopt unit-of-dose blister packs that make it difficult to obtain the quantities of pills needed for crushing to achieve euphoric effects. At an FDA meeting on opioid abuse in late January, FDA called for industry to voluntarily adopt the recommended packaging. It also is asking suppliers of bulk substances and online vendors to “exercise public health judgment” in limiting access to this product. Gottlieb told the Alliance that FDA will look further at whether it has authority to require that all dangerous pain drugs be distributed in blister packs to support more limited prescribing and dispensing.

A thorny issue for Gottlieb is the Trump administration’s support for Congressional “right-to-try” legislation to facilitate patient access to life-saving experimental therapies. In response to questions, Gottlieb said that FDA continues to provide technical assistance to those crafting proposals on this topic and expressed optimism that Congress will adopt legislation that will “work on behalf of patients.” Dozens of disease and patient groups, including the National Organization for Rare Disorders, are opposing the lead right-to-try measure for fear it will expose desperate patients to unproven, and possibly harmful, test therapies. The legislation does little to address manufacturer supply issues, the main factor limiting expanded access, and it could delay FDA approval of safe and effective new therapies.

Gottlieb also acknowledged challenges in dealing with government shutdowns and staffing issues. He said that FDA is launching a pilot program to speed up its very slow hiring process. And he recognized that many members of FDA’s leadership team have been on the job a long time and are approaching retirement age, necessitating a focus on succession planning across the agency. “If I could keep Janet Woodcock in her position another 25 years, I would,” Gottlieb quipped, “but I don’t think I’ll be able to do that.”