Capitol News

WASHINGTON, D.C. – U.S. Rep. Elissa Slotkin (MI-07) is once again working to lower the cost of prescription drugs through new legislation that will prevent pharmaceutical companies from abusing the current patent process to maximize profits.

Right now, pharmaceutical companies are able to abuse the patent and court system to block or slow generic drugs from entering the market. The Increasing Prescription Drug Competition Act expands the U.S. Food and Drug Administration's (FDA) ability to quickly approve generic drugs under certain conditions, thus preventing pharmaceutical companies from abusing the patent process as a means to stifle competition.  

You can find the text of the bill HERE. 

“As Big Pharma uses every tool at their disposal to prop up drug prices, we need to do the same to bring them down,” said Slotkin. “Right now, many pharmaceutical companies abuse the patent system – layering patents over patents – to keep generic, low-cost drug options from coming to market. It keeps prices artificially high and results in less money in people’s pockets. This legislation will make it easier for generics to hit shelves, increase competition and drive down costs.”

The FDA often requires that drug manufacturers have a Risk Evaluation and Mitigation Strategy (REMS) program for potentially dangerous medications – for instance, requiring training for doctors to prescribe the drug. Pharmaceutical companies sometimes patent their REMS program as a way to slow or block generic versions of the medication from entering the market. This bill enables the FDA to immediately approve generic drugs – instead of the normal 30-month approval stay – if the only barrier to approval is a REMS patent. In addition, Slotkin’s bill stops pharmaceutical companies from abusing the patent and court system by ensuring that if a drug company sues to stop a generic over a REMS patent, the lawsuit may go on but it cannot stop the sale of the generic drug.

The legislation comes after Slotkin hosted U.S. Health and Human Services Secretary Xavier Becerra in Michigan’s 7th District for multiple events focused on pharmaceutical shortages, maternal health disparities, and efforts to lower prescription drug prices. 

Slotkin has been a longtime advocate for strengthening supply chains for critical pharmaceuticals. She co-founded the Domestic Pharmaceutical Manufacturing Caucus, a working group in Congress focused on restoring America’s drug manufacturing industry in order to head off potential supply chain disruptions. 

Last month, she unveiled new legislation to expand supply of critical drugs during shortages. The legislation followed a letter she joined in May alongside U.S. Senators Debbie Stabenow (MI) and Gary Peters (MI), urging the Federal Drug Administration to do everything in its power to mitigate the dire shortage of cancer drugs that has reached crisis levels in recent months.

In December 2022, her Strengthening America’s Strategic National Stockpile Act, which would make improvements to America’s Strategic National Stockpile of medical supplies, was passed by Congress and signed into law.

Slotkin’s Real Time Benefits Act went into effect earlier this year and enables people to compare drug prices at the pharmacy counter so they can be sure they’re getting the best deal.

Original source can be found here.