President Trump recently signed the SUPPORT, or Substance-Use Disorder Prevention That Promotes Opioid Recovery and Treatment, for Patients and Communities Act (the “Act”), aimed at curbing the overuse of opioids in the United States. The Act is far-reaching, and it includes changes to Medicare, Medicaid and other public health efforts. Certain sections, especially those in Title III, “FDA and Controlled Substance Provisions,” will have a direct impact on manufacturers of certain products used to treat chronic pain.
Within Title III, sections 3001, 3012, 3032 and 3041 amend the Federal Food, Drug and Cosmetic Act to expand the authority of the Secretary of Health and Human Services to regulate controlled substances.
Section 3001, “Clarifying FDA Regulation of Non-Addictive Pain Products,” first requires the Secretary to hold a public meeting, before October 24, 2019, “to address the challenges and barriers of developing non-addictive medical products intended to treat acute or chronic pain or addiction.” Within a year of the public meeting, the Secretary is to issue final guidance documents to include the FDA’s method for evaluating when “opioid-sparing data,” meaning data about a drug’s ability to reduce or replace the use of opioids or other controlled substances, could be included in the labeling of non-addictive products for pain treatment.
In Section 3012, entitled “Notification, Nondistribution, and Recall of Controlled Substances,” the Act allows the Secretary to issue an order requiring “manufacturers, importers, distributors, or pharmacists” to immediately cease distribution of a controlled substance if the Secretary “determines there is a reasonable probability that a controlled substance would cause serious adverse health consequences or death.” If such an order is contemplated, the manufacturer will be given an opportunity to consult with the agency before it is issued. Any manufacturer subject to an issued order will be granted an informal hearing within 10 days if modification or withdrawal of the order is sought. At this hearing, the Secretary can vacate the order, continue the order for an unspecified date, or recall the controlled substance.
Section 3032, “Safety-Enhancing Packaging and Disposal Features,” amends the Food, Drug, and Cosmetic Act to require safety packaging for controlled substances. This section grants the Secretary authority to require “a risk evaluation mitigation strategy” when a drug has “a serious risk of an adverse drug experience,” defined to include a risk of abuse or overdose, whether accidental or intentional. Mitigation strategies may include requiring the manufacturer to use “unit dose packaging” or to dispense the drug with “safe disposal packaging or [a] safe disposal system” that renders the drug non-retrievable.
Section 3041, “Clarifying FDA Postmarket Authorities,” addresses labeling issues related to “reduced effectiveness” of controlled substances. First, one of the definitions of an “adverse drug experience” is expanded to include “reduced effectiveness under the conditions of use prescribed in the labeling, but which may not include reduced effectiveness that is in accordance with [the] labeling,” rather than limiting the definition to “any failure of expected pharmacological action of the drug.” This section also requires the Secretary to notify manufacturers if he or she becomes aware of “new information . . . including new safety information or information related to reduced effectiveness, that the Secretary determines should be included in the labeling . . . .”
Finally, section 6111, entitled “Fighting the Opioid Epidemic with Sunshine,” amends portions of the Social Security Act and broadens the list of recipients whom a drug or device manufacturer must report to the Secretary if the manufacturer provides those recipients with payments or anything of value. While the list formerly included only “physicians” and “teaching hospitals,” it has been expanded to include physicians’ assistants, nurse practitioners, clinical nurse specialists, certified nurse anesthetists, and certified nurse mid-wives. This change does not take effect immediately but applies to information required to be submitted on or after January 1, 2022.
While the Act may not have immediate consequences, these changes to the FDA’s regulatory authority will have an eventual impact on manufacturers of products used for the treatment of chronic pain and addiction. Under the Act, manufacturers of these products will be faced with increased regulation and oversight, which may include an order requiring removal of products from the market. By staying informed, manufacturers can prepare for and mitigate the impact to their business.