House panel advances 25 opioid bills

The House Energy and Commerce Committee on Wednesday advanced 25 bills tackling the opioid crisis to the full House for a vote.

The bills focus on different facets of the opioid crisis. Federal data shows that more than 42,000 Americans died in 2016 due to an opioid overdose.

“These bills will help protect our communities and bolster enforcement efforts, strengthen our prevention and public health efforts, and address coverage and payment issues in Medicare,” said Rep. Greg Walden, R-Ore.

One of the bills aims to give pharmacists educational materials to help them detect fraudulent prescriptions of opioids, aiming to clamp down on rampant overprescribing of the powerful painkillers.

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Another bill would help support establishing Comprehensive Opioid Recovery Centers that offer treatment options.

One piece of legislation seeks to work with drug manufacturers on ways patients can return unused opioids. Options include adding a pouch to packaging so a patient can send unused pills to a facility for incineration.

The committee plans to hold another hearing on May 17 to advance another raft of more than 20 opioid bills.

The committee also advanced several other healthcare bills, including one to reauthorize the user fee program for animal drugs.

It also advanced the first overhaul to the Food and Drug Administration’s approval process for over-the-counter drugs since 1972.

The Over-the-Counter Monograph Safety, Innovation and Reform Act of 2018 would create a user fee system to fund changes to the approval system.

The agency does not fully approve an OTC drug before it hits the market. Intead, the drug has to meet a monograph that outlines the ingredients, dosage, labeling and indications. The bill would modernize the process.

But Democrats and Republicans clashed over a controversial part of the bill, which would give a drug maker 18 months of market exclusivity for a new OTC drug.

Rep. Frank Pallone, D-N.J., the committee’s top Democrat, offered an amendment that would shrink the exclusivity period to 12 months. Democrats charged that the long timeframe would result in higher prices.

“A drug company could get 18 months of exclusivity for another OTC drug that is no better than an older medicine all by introducing a new delivery formulation,” said Rep. Jan Schakowsky, D-Ill. “This could mean taking a tablet and making it into a gummy or a dissolvable strip and driving up the price.”

But Republicans countered that the 18-month period is right because it would take a year for a new product to be accepted.

The amendment failed 30-24, but the full bill advanced without objections via a voice vote to the full House.

Committee leaders have said they hope to get the opioid bills through the House by the Memorial Day recess.

Walden told reporters Tuesday that floor time will be up to House leadership.

“They are very aware of our work and no decisions have been made yet as to how these might get packaged up,” he said.

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