Draft Senate Bill Would Let FDA Require Smaller Opioid Packs (1)

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Jeannie Baumann Washington Reporter Randy Kubetin Washington Managing Editor

By Jeannie Baumann

The FDA could have the authority to encourage shorter-term prescriptions for pain medications like AbbVie’s Vicodin as a way of curbing new opioid addictions, under a key senator’s proposal.

Sen. Lamar Alexander (R-Tenn.), who leads the Senate’s health panel, released two draft bills March 26 to beef up the Food and Drug Administration’s ability to respond to the opioid crisis. The first of these measures would give the agency the authority to require drug manufacturers to package certain opioids in blister packs, or pre-formed plastic packaging. The draft bill would make it simpler for doctors to write prescriptions for smaller amounts of opioids, he added.

“It would also encourage manufacturers to provide a safe way to dispose of leftover opioids along with the prescription a patient picks up—to prevent unused opioids from ending up in the wrong hands,” Alexander, who is the chairman of the Senate Health, Education, Labor, and Pension Committee, said in a statement. He said he wants to ensure the FDA “has every tool it needs to fight the opioid crisis, and the draft legislation released today will take the next step towards making that possible.”

In 2015, more than 33,000 Americans died as a result of an overdose of opioids, including prescription opioids, and an estimated 2 million people in the U.S. suffered from substance use disorders related to prescription opioid pain relievers, according to the National Institute on Drug Abuse, part of the National Institutes of Health. About 21 percent to 29 percent of patients who received prescriptions for chronic pain misuse them, NIDA’s data also indicated.

The data are particularly dangerous with the rise of illegal versions of the synthetic opioid fentanyl. Overdose deaths involving synthetic opioids including fentanyl doubled from 2015 to 2016, according to data from the Centers for Disease Control and Prevention. Developed in the 1960s by Janssen Pharmaceuticals’ namesake, Paul Janssen, fentanyl is designed to treat severe pain such as in cases of patients with advanced cancer. But illegal drug markets have peddled counterfeit versions of the drug for its heroin-like effect.

“We look forward to reviewing the discussion draft legislation released today by Chairman Alexander and are committed to engaging in ongoing dialogue as proposals are developed and considered by policymakers,” Janssen Pharmaceuticals Inc. spokeswoman Jessica Castles Smith said in a March 26 email. Janssen is the research and development arm of Johnson & Johnson.

FDA Response

The FDA is reviewing the legislation and appreciates “the opportunity to work with Congress on such an important public health issue,” agency spokesman Michael Felberbaum told Bloomberg Law in a March 26 email. But FDA Commissioner Scott Gottlieb already has expressed his support for blister packs as a way of curbing new addiction, including as part of a Jan. 30 statement.

“At the FDA, we believe one of our key roles in addressing the opioid epidemic is to reduce new addiction,” Gottlieb said in that statement, adding the agency is “actively exploring” how changes in packaging can give providers better options for tailoring how much they prescribe to the clinical need. “This is especially true when it comes to immediate release formulations of opioid drugs like Vicodin and Percocet which are typically meant for short-term use. If more immediate release opioid drugs, in particular, were packaged in three or six-day blister packs,” more doctors may opt for these shorter durations of use, the FDA leader said. AbbVie Inc. makes Vicodin (hydrocodone bitartrate and acetaminophen tablets); Endo Pharmaceuticals Inc. is the maker of Percocet (oxycodone and acetaminophen).The American Medical Association, which represents doctors, said it’s too early to comment on the draft legislation, but a spokesperson told Bloomberg Law in a March 26 email “we look forward to reviewing and discussing the proposal with the committee before taking a position.” The American Academy of Pain Medicine also said it was too soon to comment.

Seizing Drugs at Border

The other draft bill Alexander announced aims to improve coordination between the FDA and the Customs and Border Protection so federal authorities can improve their capabilities in finding and seizing illegal drugs at the U.S. border.

The bills announced by Alexander build on a series of six bipartisan hearings the HELP Committee has held on addressing the opioid crisis. Meanwhile, the House Energy and Commerce Committee is working on a group of 25 bills that lawmakers hope to bring to the House floor by Memorial Day. Rep. Richard Hudson (R-N.C.) has been working with Rep. G.K. Butterfield (D-N.C.) on a draft bill to “to require improved packaging and disposal methods with respect to certain drugs, and for other purposes,” a House aide told Bloomberg Law. Butterfield and Hudson also both raised during a recent hearing on opioid epidemic. “The goal of their effort is to bolster FDA’s ability to take steps that reduce the volume of unused opioids in people’s medicine cabinets that are at risk of diversion,” the aide told Bloomberg Law.

To contact the reporter on this story: Jeannie Baumann in Washington at jbaumann@bloomberglaw.com

To contact the editor responsible for this story: Randy Kubetin at rkubetin@bloomberglaw.com

For More Information

Alexander’s draft bill on blister packs is available at https://bit.ly/2G8Xd5H. Reps. Hudson and Butterfield’s draft bill is available at http://docs.house.gov/meetings/IF/IF14/20180321/108049/BILLS-115pih-FDAPackagingandDisposal.pdf.

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