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July 28, 2022

Trone, Meuser Introduce EFFECTIVE Act to Grant the FDA More Authority to Clamp Down on Ineffective Opioids Entering the Drug Market


July 28, 2022

Contact: Sasha Galbreath, 

Trone, Meuser Introduce EFFECTIVE Act to Grant the FDA More Authority to Clamp Down on Ineffective Opioids Entering the Drug Market

WASHINGTON, D.C. — Today, Congressmen David Trone (D-MD) and Dan Meuser (R-PA) introduced the Ensuring the FDA Fully Examines Clinical Trial Impact and Vitalness before Endorsement (EFFECTIVE) Act to allow the FDA to deny a new drug application for an opioid if it is not clinically superior to other commercially available drugs. 

This effort would provide further authority to the FDA to review the potential public health impact of every new opioid approval, and deny applications for new drugs if they cannot prove their ability to serve as a safer or more effective option for patients. 

Stemming from the Sackler family and Purdue Pharma’s unethical marketing of OxyContin in the 1990s, excessive opioid prescribing and opioid use disorder have continued to wreak havoc in American communities. This epidemic has been exacerbated by a saturation of opioids in the drug market, often approved without sound evidence that the new drugs are improvements to current offerings. While opioids are often prescribed in good faith and can very well help patients manage pain, their addictive properties have led to millions of Americans becoming dependent on the drugs. Last year, over 107,000 Americans died from drug overdoses – and over one million Americans have died from overdoses since 1999.

“As leaders, we need to take control of our own destiny in addressing the nation’s opioid epidemic. OxyContin killed hundreds of thousands of Americans and left millions more struggling with substance use disorder to this day,” said Congressman Trone. “Despite the loss, we remain committed to action. The EFFECTIVE Act will give the FDA the authority it needs to curb less effective opioids at the source. This legislation will save lives.”

“This legislation would help us avoid past tragic outcomes regarding the efficacy and safety of new drugs before they are on the market and prescribed to consumers,” said Congressman Meuser. “Giving the FDA authority to thoroughly vet new medications to make sure they can be prescribed to patients looking for the safe alleviation of pain will hopefully keep them for experiencing unintended and tragic consequences.  This bill would ensure only superior and tested medications would make it to our medicine cabinets.”

In the Senate, the EFFECTIVE Act was introduced by Senators Joe Manchin (D-WV) and Mike Braun (R-IN) in May 2022.

For bill text, click here.

For one-pager, click here.

Congressman David Trone was elected to the House of Representatives in November 2018 to serve the 6th District of Maryland, which includes all or part of Montgomery, Frederick, Washington, Allegany, and Garrett Counties. Trone serves on the Appropriations, Veterans’ Affairs, and Joint Economic Committees. In Congress, Trone is fighting to make progress on issues that matter to Marylanders, including the mental health and addiction crises, criminal justice reform, and funding for medical research.

Follow Congressman Trone at @RepDavidTrone for updates on TwitterFacebook, and Instagram.