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Massive opioid legislative package set for Senate vote

Senate Republican and Democratic leaders have reached a bipartisan deal on a massive package of over 70 bills intended to combat the U.S. opioid crisis and are expected to vote on the legislation next week, Majority Leader Mitch McConnell, R-Ky., confirmed on the chamber's floor.

The Sept. 6 agreement came after months of haggling over legislation passed earlier this year by five Senate committees — Health, Education, Labor and Pensions; Finance; Judiciary; Banking, Housing and Urban Affairs; and Commerce, Science and Transportation.

If adopted, the package will need to be reconciled with bipartisan legislation passed in June by the House, which contains nearly 60 measures.

"There is a bipartisan urgency to work with our House colleagues to get the legislation to the president's desk," said Sen. Lamar Alexander, R-Tenn., chairman of the Senate health panel, who led the effort to reach the deal.

The Senate legislation includes measures authored by Sen. Rob Portman, R-Ohio, aimed at stopping illegal drugs, like fentanyl and its analogues, from entering the U.S. at the border.

The legislative package includes provisions intended to strengthen coordination between the U.S. Food and Drug Administration and the U.S. Customs and Border Protection. It also would provide the FDA access to innovative detection technology and testing equipment to facilitate near-real-time information sharing.

Portman noted the bill includes provisions that would hold the U.S. Postal Service to the same screening standards as private mail carriers and require it to provide advance electronic data on international packages entering the U.S., which he said would allow law enforcement to identify suspicious packages, stop them in transit, test them and keep drugs like fentanyl from entering the nation's communities.

In addition, the Senate legislation would permit the FDA to require drugmakers to package their prescription opioids in so-called blister packs in set amounts, such as 3- or 7-day supplies — an action promoted by Commissioner Scott Gottlieb, who has been a proponent of cutting back on the number of pills per prescription.

The intent of the mandate is to reduce overprescribing of opioids, which have been responsible for the overdose deaths of about 40 Americans per day. That number rises to 115 people per day when including illicit opioids, such as fentanyl and heroin, the Centers for Disease Control and Prevention reported.

Last month, the CDC said U.S. overdose deaths from opioids had soared to a new high of 72,000 in 2017 under the Trump administration.

The Senate legislation calls for Health and Human Services, in consultation with the U.S. attorney general, to submit a report to Congress on the impact of federal and state laws and regulations that limit the length, quantity or dosage of opioid prescriptions.

Driving innovative treatments

The legislation includes provisions aimed at boosting the development of non-addictive products to treat pain or addiction.

It seeks to clarify the FDA's development and regulatory pathways for drug and device manufacturers through guidelines about those products.

If adopted, the legislation would require the agency to hold at least one public meeting, if not more, on the challenges and barriers to developing those products, including how the risk of misuse and abuse may be incorporated into the regulators' assessments, novel clinical trial designs and evidentiary standards related to opioid sparing.

Lawmakers also included provisions requiring the FDA to issue new sets of guidelines, including ones to address expedited pathways and clarify the agency's interpretation of how its qualification parameters for its breakthrough designation and accelerated approval process apply to non-addictive pain or addiction treatments.

The FDA also would be required to produce guidelines on the appropriate use of pain endpoints across review divisions, as well as for products intended to reduce, replace or avoid patients' use of opioids to control pain.

Also included in the legislation is a provision that would give the U.S. National Institutes of Health greater flexibility to move quickly on high-impact research projects on new non-addictive painkillers under a mechanism known as "other transaction authority," which the agency's director, Francis Collins, has long sought.

Having that authority would give the NIH the flexibility to push forward with "maximum speed" on research that shows the most promise and "pull the plug" on those projects that are not performing, Collins told lawmakers during a Dec. 5, 2017, Senate hearing.

He noted the NIH was previously granted other transactional authority in other areas, such as precision medicine, but it takes an act of Congress to allow the agency to use it in other programs.

Medication-assisted therapy

The Senate legislation also includes provisions aimed at promoting the development and greater use of medication-assisted treatments, or MATs, which are used to stabilize brain chemistry, reduce or block the euphoric effects of opioids, relieve physiological cravings and normalize body functions.

There are currently three MATs approved for the U.S. market: buprenorphine, methadone and naltrexone.

Last month, the FDA's Gottlieb issued new guidelines outlining ways for biopharmaceutical companies to consider measuring and demonstrating the effectiveness and benefits of new or existing MATs.

He noted that several barriers were blocking the use of MATs, including a lack of clinician training in identifying and treating opioid-use disorder and negative attitudes and misunderstandings about the medications, including the mistaken belief that the drugs merely replace one addiction with another.

The Senate legislation would codify a 2016 rule giving qualified physicians the authority to prescribe MATs for up to 275 patients.

It also would allow doctors who have recently graduated in good standing from an accredited school of allopathic or osteopathic medicine and who meet the other training requirements to prescribe MATs.

In addition, the legislation would authorize a grant program to support development of curriculum to help other healthcare practitioners obtain waivers to prescribe MATs.