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Pelosi urges Senate to act after drug price hikes; generics fight delay ban

House Speaker Nancy Pelosi, D-Calif., called on the U.S. Senate to take action to adopt legislation to lower Americans' costs of prescription drugs after a number of companies raised the prices of their medicines Jan. 1.

"Enough is enough," Pelosi said in a Jan. 2 tweet.

SNL ImageHouse Speaker Nancy Pelosi
Source: AP Photo

As of Jan. 3, 102 manufacturers had raised their prices on 445 drugs, with a median increase of 5% and an average increase of 5.2%, according to data reported by the healthcare research company 3 Axis Advisors.

Spokesman Antonio Ciaccia emphasized some manufacturers have yet to disclose their pricing changes.

Vincent Rajkumar, a professor of medicine at the Mayo Clinic in Rochester, Minn., called out Gilead Sciences Inc. on Twitter for raising the prices of its HIV medicines.

"We cannot go on like this," Rajkumar tweeted.

According to 3 Axis Advisors, Gilead upped the prices of its HIV drugs Truvada, Descovy, Biktarvy, Genvoya and Odefsey by 4.8% each.

Neos Therapeutics Inc.'s attention deficit hyperactivity disorder drug Cotempla XR-ODT had the greatest increase so far in 2020 — 13.24%.

Neos launched Cotempla XR-ODT, a central nervous system stimulant, in 2017, but its active pharmaceutical ingredient was initially approved in the U.S. in 1955.

Pelosi noted the House adopted her drug pricing bill, H.R. 3, the Elijah E. Cummings Lower Drug Costs Now Act, on Dec. 12, 2019, in a 230 to 192 vote, with two Republicans joining all House Democrats in passing the measure.

In a Dec. 30, 2019, statement, the speaker vowed that when Democrats return to Capitol Hill this week after Congress' holiday break, "our priority will be to continue a drumbeat across America to press" the White House and the Republican-controlled Senate to pass her bill into law.

The legislation would permit the federal government to negotiate the prices of the most expensive prescription drugs on behalf of the Medicare program and the commercial insurance market.

However, Senate Majority Leader Mitch McConnell, R-Ky., has already said he has no plans to ever bring up the bill for a vote in his chamber.

Generics group fights pay-for-delay ban

Meanwhile, last week a federal district judge in California denied the generic drug industry's attempt to block the state's new law aimed at deterring agreements in which brand-name manufacturers pay makers of lower-cost medicines to delay entry of their products onto the U.S. market.

The Association for Accessible Medicines, which lobbies on behalf of the generic drug industry, filed a notice Jan. 2 with the U.S. Court of Appeals for the 9th Circuit in San Francisco of the group's intent to appeal the district court's ruling.

California's law, known as AB 824, creates a presumption that the so-called pay-for-delay agreements, also known as reverse payment settlements, are anticompetitive and violate the state's antitrust laws.

AAM argued the law was unconstitutional and that the pay-for-delay agreements help generic companies avoid patent litigation and bring their products to the market before the branded drugs' patents expire.

In his Dec. 31, 2019m ruling, Judge Troy Nunley of the U.S. District Court for the Eastern District of California said AAM had failed to establish a likelihood of success on the merits of its claims or that the plaintiffs would suffer irreparable harm in the absence of a preliminary injunction.

In addition, the court rejected AAM's argument an injunction would be in the public interest.

"At this juncture, how AB 824 will impact the public interest is purely speculative," Nunley wrote in his opinion. "The court cannot predict how the market will react to this new law, nor should it. There is no comparable law in another state nor under federal law, so the court has no facts before it to base such a determination. Therefore, the balance of equities does not tip in one direction or the other, and it certainly does not tip sharply in plaintiff's favor. Thus, this factor does not support the imposition of an injunction against the enforcement of AB 824."

SNL Image

Health and Human Services Secretary Alex Azar swearing in Stephen Hahn as U.S. Food and Drug Administration Commissioner on Dec. 17, 2019.
Source: U.S. Department of Health and Human Services

New FDA chief lures official from CMS

New U.S. Food and Drug Administration Commissioner Stephen Hahn started off his tenure at the agency by luring a top official away from the Centers for Medicare and Medicaid Services to advise him.

Anand Shah, a senior medical adviser for innovation at CMS, previously worked with Hahn when they both were radiation oncologists at the University of Pennsylvania a number of years ago.

"Anand Shah has been a colleague and friend for years," Hahn said in a statement to S&P Global Market Intelligence. "I have great respect for him as a doctor and also as a government servant and I look forward to him contributing to FDA's mission."

Hahn was sworn in as FDA commissioner on Dec. 17, 2019. He takes over at the agency at a time when it has been successful at approving new innovative medicines — clearing the second highest number of new molecular entities for the U.S. market in the past two decades in 2019 — as well as generic drugs.