Blumenthal: Bill would speed generic drug approval, reducing costs

At Tuesday's panel: (l-r) Healthcare Advocate General Counsel Demian Fontenella, Comptroller Kevin Lembo, U.S. Sen. Richard Blumenthal, Hartford Hospital Medical Oncology Director Dr. Peter Schauer, Hartford Hospital Pharmacy Director Mike Rubino

Kyle Constable

At Tuesday’s panel: (l-r) Healthcare Advocate General Counsel Demian Fontenella, Comptroller Kevin Lembo, U.S. Sen. Richard Blumenthal, Hartford Hospital Medical Oncology Director Dr. Peter Schauer, Hartford Hospital Pharmacy Director Mike Rubino.


U.S. Sen. Richard Blumenthal, D-Conn., plans to introduce legislation intended to speed up FDA approval of generic prescription drugs and combat the “astronomic rise” in the cost of health care, he said Tuesday.

The bill, titled the “Fast Generics Act,” will be sponsored by Blumenthal and a number of other legislators. He announced the proposal and called for more federal action to combat high prescription drug prices during a panel discussion at Hartford Hospital on Tuesday.

“The astronomic rise in health care costs is due to lax enforcement, broken markets and, unfortunately, unvarnished greed,” Blumenthal said during the event. “There are more fundamental problems that need to be addressed. Many of the companies are too big – and are monopolies – and have misused their monopolistic power.”

Blumenthal called for stronger enforcement of federal antitrust laws and more transparency in drug costs, saying that claims of research and development necessitating the cost increases need to be verifiable.

Joining Blumenthal on the panel were state Comptroller Kevin Lembo and Healthcare Advocate General Counsel Demian Fontanella as well as Hartford Hospital’s Pharmacy Director Mike Rubino and Medical Oncology Director Dr. Peter Schauer.

Lembo, who is tasked with purchasing health care for about 200,000 state employees and retirees, said the factor driving up health costs the most in recent years has been rising pharmaceutical prices. He said the state is seeing the cost of prescription drugs increase 17 percent annually. The cost of speciality drugs for rare diseases, which Lembo said make up about 1.2 percent of all drugs purchased, comprises 54.7 percent of the state’s pharmaceutical expenses.

And Lembo said that percentage is not static.

“That number is growing, both in the number of prescriptions – though not very quickly – but certainly in the total span as well,” Lembo said. “That is, by any definition, an unsustainable situation.”

While Lembo conceded annual increases in cost are expected, he said pharmaceutical companies are raising prices “beyond what had been expected and, frankly, beyond what’s rational.”

Schauer said during his 35 years of practice in medicine that there has been a growing “disconnect between the value of new medications and cost of new medications.” Rubino added that some of this has to do with the prescription drug supply being limited by slower FDA approval of generics.

Rubino cited a 2015 study by the University of Utah’s Drug Information Service that found the number of prescription drugs considered to be “in shortage” had risen by 74 percent between 2010 and 2015. He said introducing generic drugs to the market more quickly would work to counter this issue.

However, Rubino also said the annual price increases imposed by the pharmaceutical companies far exceed what would be expected in a market driven solely by supply and demand.

Blumenthal said introducing generic prescription drugs more quickly will not be “the savior,” as their costs could rise over time as well, but they are a part of the solution.

The bill “will enable more drugs to come to market – generic drugs – more quickly at lower prices,” Blumenthal said.

Some believe the legislation does not go far enough.

Paul Pescatello, the chair of the Connecticut Bioscience Growth Council, said other major developed countries are getting “a free ride” off costly research and development conducted and paid for in the United States. In addition, he said many of the drugs are manufactured in the United States as well, another expense placed on the backs of American consumers.

Pescatello asked whether Blumenthal would consider legislation to compel other developed countries to share the cost, but Blumenthal said he is “not optimistic” about being able to enforce that kind of legislation at this time.

Similar legislation to Blumenthal’s has already been introduced in the House of Representatives with bipartisan support. Using the same name, the Fair Access for Safe and Timely (FAST) Generics Act was first introduced in the 113th Congress, but was not passed by the House. U.S. Reps. Steve Stivers, R-Ohio, and Peter Welch, D-Vt., are the legislation’s primary sponsors in the 114th Congress and reintroduced the bill last September.

Lembo said the state government has worked to educate patients and talk with healthcare providers in an attempt to reduce any unnecessary costs from administrative issues. He said the most significant challenge is the inability at the state level to police “bad actors,” who temporarily drive up prescription drug prices until they are caught, “pack up their tents and run away.”

Reducing the data exclusivity period – the length of time test data must be provided to the FDA in order to receive federal approval – would be a key step in bringing cheaper drugs into the market, according to Lembo. In a press release last October, Lembo called for shortening the span to seven years from the current standard, 12 years.

He also said changes to the criteria of federal antitrust violations need to be considered. While he could not name any specific changes, Lembo said the legislation as it exists is failing to protect consumers as it was intended.

“Antitrust laws were put in place to protect consumers and to make sure that a market is thriving and that it rewards innovation, but at the same time doesn’t allow for gouging,” Lembo said. “I think that sometimes we wander away from that, and any attempt to engage and refine that policing is seen as somehow not supportive of public markets, which is kind of crazy.”