As EpiPen prices soar, Sen. Paul hopes bill creates more competition, cheaper prices for generics

09/09/2016 09:48 PM

LOUISVILLE — While he may have to tangle with one of the world’s largest drugmakers to get legislation aimed at getting more generic versions of the EpiPen in the marketplace, Sen. Rand Paul said Friday that he hopes others in the pharmaceutical industry will see opportunity.

The price of EpiPen two-packs has surged to $600, up from $57 in 2007, sparking outrage across the U.S. The dramatic increase has caused many to accuse EpiPen’s manufacturer, Mylan Pharmaceuticals, of price gouging.

During a roundtable discussion with medical professionals at Jewish Hospital’s Rudd Heart and Lung Center, Paul said that the U.S. Food and Drug Administration has made it difficult to introduce generic versions of the EpiPen, which injects epinephrine to treat severe allergic reactions, in the U.S.

What’s more, Paul said Mylan virtually holds a monopoly on the device until 2025, when its patent is set to expire. In 2009, Mylan filed a patent infringement lawsuit another drugmaker, Teva Pharmaceuticals, that was planning a generic version of the EpiPen.

The case was ultimately settled out of court in 2012, but the FDA has yet to approve Teva’s generic EpiPen.

“When you sue them, you get a 30-month stay automatically, so everybody sues every time,” Paul said.

Paul plans to file a bill that would make it easier to approve generic versions of the EpiPen that are already available in Europe, saying more competition would lower prices of the life-saving drug.

“What we’re hoping to do with our bill is to bring those drugs over here, have the committee at the FDA look at the studies, and then vote on whether to approve them,” Kentucky’s junior senator told reporters after the meeting.

Paul’s bill could be in the crosshairs of Pfizer, one of the globe’s largest drug companies that actually manufactures in the epinephrine used in EpiPens.

Asked about potential backlash on Capitol Hill from pharmaceutical companies, Paul said those that make generic EpiPens in Europe will likely back his proposal.

“If you’re a pharmaceutical company in Europe selling it, which may be an American company in Europe selling it, you may like it actually because it may be easier to get your drugs to market,” he said.

EpiPen prices and generics weren’t the only topic of conversation Friday as health professionals also shared their experiences combating the state’s heroin epidemic.

Dr. Charles Woods says he’s seen an uptick in the number of infants exposed to hepatitis C, and Dr. Kal Jundi has noticed the same trend with newborns born addicted to opiates.

In some cases, Jundi says he has treated multiple children from the same mother.

“The problem that we’ve always faced with them is that while they’re pregnant they qualify for Medicaid, which then gets them into the clinic, which then gets them the medication, which then is helpful, and then the baby has to be treated, which we treat,” he said.

“The thing is, people don’t understand the babies are not perfect afterwards. They’re still not an easy baby to care for. We send it to them at about 4 to 5 weeks of age, which is about the time that their Medicaid expireswhich then they cannot get the Subutex, which means they go back into heroin.”

Paul’s opponent in the Nov. 8 election, Lexington Mayor Jim Gray, criticized Paul and other Republicans in Congress Sept. 1 for not including funding for the Comprehensive Addiction and Recovery Act that was signed into law in July. Democrats are seeking about $600 million for the new law that targets opioid abuse.

Paul told reporters that he expects money for CARA will be appropriated as Congress crafts the federal budget.

“The interesting thing is it hasn’t really been a partisan issue,” he said. “Republicans and Democrats have come together on this. I’ve worked with the Democratic senator from Massachusetts on this, so I think it’s really an issue that shouldn’t divide us and be some thing that we have to bring up in a campaign. It’s not really that partisan. Drug overdoses are a travesty, and we should do everything possible to try to prevent them.”


Subscribe to email updates.

Subscribe and get the latest political intelligence delivered to your inbox.