Opioid Abuse, Drug Pricing Raised at NIH Budget Hearing

By Jeannie Baumann

March 16 — Opioid drugs developed with features to deter abuse of these powerful painkillers should be covered by insurance companies despite their higher costs, the chairman of the House Appropriations Committee said March 16.

“If any of these insurance companies are listening, they would be very wise to allow coverage of these abuse-deterrent drugs because they don’t want to know what would happen if they don’t,” Rep. Hal Rogers (R-Ky.) said during a hearing, referring to the harmful health effects on the public if patients can't have these newer drugs. Rogers made his comments less than a day after the Centers for Disease Control and Prevention issued new prescribing guidelines on opioids to curb an overdose epidemic that the CDC has linked to increased prescribing and sales of opioids.

“Thanks in part to deceptive marketing practices and reckless overprescribing, these drugs have become a default solution, it seems, for any pain rather than the severe pain for which they were intended,” Rogers said during a hearing on the NIH budget.

Nora D. Volkow, director of the National Institute on Drug Abuse, part of the National Institutes of Health, said reimbursement is likely one reason more doctors aren’t prescribing the costlier, abuse-deterring opioids.

“We have to create a system that incentivizes the utilization of these abuse-deterrent formulations that by default in general are going to be more expensive,” she said, attributing the higher price tags to the costs associated with developing new drug formulations.

CDC guidelines are a step forward in helping to improve prescription practices, Volkow said.

“There is an increased awareness that current prescription practices of opioids cannot continue the way they are doing right now.” she said. “It’s unacceptable.”

NIH Open to March-In Rights

The hearing addressed drug pricing and, specifically, whether the NIH would ever exercise its march-in rights. Under the Bayh-Dole Act, the federal agency that funded research leading to an invention can “march in” and issue patent licenses on its own—thereby ignoring exclusivity rights—if “reasonable terms are not being met’’ on drug pricing and if the agency has the intellectual property on the drug's molecule.

“We are totally open to considering that on a case-by-case basis,” NIH Director Francis S. Collins told the House Appropriations labor-health subcommittee.

Rep. Rosa DeLauro (D-Conn.), the top Democrat on the appropriations panel, said that in many cases, taxpayer-funded research leads to drugs that are sold back to taxpayers at exorbitant prices.

“I realize the pharmaceutical companies invest their resources, they bring a new drug to market, they should profit from that innovation,” she said. “But what I want to know is why U.S. taxpayers are getting gouged for drugs that wouldn’t exist without the significant investment of U.S. taxpayers.”

Collins responded, “Certainly my heart goes out—as all of us do—to patients who are in need of a therapeutic which is outside of their financial means to be able to gain access to it. That really ought to be the thing that drives us to come up with better solutions.”

DeLauro was one of 50 lawmakers who signed a letter to Health and Human Services Secretary Sylvia Mathews Burwell calling for the NIH to exercise its march-in rights. Collins said “we read the letter carefully” but ultimately opted not to march in because no cases have passed the reasonable term test.

“What’s a reasonable term?” DeLauro asked.

“Well that’s very much where it gets down to the nitty gritty, doesn’t it?” Collins replied, adding later, “We get it, that this is a serious issue.”

To contact the reporter on this story: Jeannie Baumann in Washington at jbaumann@bna.com

To contact the editor responsible for this story: Nancy Simmons at nsimmons@bna.com

For More Information

More information on the hearing is available at http://appropriations.house.gov/calendar/eventsingle.aspx?EventID=394449.

The CDC opioid prescribing guidelines are available at http://www.cdc.gov/media/releases/2016/p0315-prescribing-opioids-guidelines.html.

The January letter calling for the NIH to exercise its march-in rights is available at http://doggett.house.gov/images/DoggettLetter1.11.pdf.