Exclusivity Provision For Biologic Drugs Stripped From Trump’s Trade Deal In Win For Dems, Slap In Face For Pharma
Democrats argue that enshrining a 10-year guarantee in the United States-Mexico-Canada Agreement would have tied Congress' hands if lawmakers wanted to change the threshold. "This deal would have caused prices of prescription drugs in those countries to skyrocket," said Rep. Jan Schakowsky (D-Ill.). Pharmaceutical lobbyists were harsh in their assessment: “This was an unforced error and very, very weak negotiating.”
The New York Times:
Trump Aides And Democrats Agree On Trade Pact With Mexico And Canada
The White House and House Democrats reached an agreement to strengthen labor, environmental, pharmaceutical and enforcement provisions in President Trump’s North American trade pact, a significant development that made it all but certain that the signature trade deal would become law. ... One of the most significant revisions will roll back protections for new pharmaceutical products, in particular an advanced class of drugs called biologics, which were initially given 10 years of patent protection from cheaper alternatives. It also removed language that would ensure patent protections when drug companies find new uses for their existing products, a process known as “evergreening.” (Cochrane and Swanson, 12/10)
Modern Healthcare:
Biologic Exclusivity Provision Stripped From Revised USMCA Deal
Biologics make up a large portion of spending on physician-administered drugs. The Medicare Payment Advisory Commission reported that biologics accounted for two-thirds of spending and all 10 of the highest-expenditure drugs in Medicare Part B in 2017. Biologic exclusivity in the United States is currently set at 12 years, but Democrats argued that enshrining a 10-year guarantee in the trilateral trade deal would have tied Congress' hands if lawmakers wanted to change the threshold. Also, Mexico and Canada both currently offer less than 10 years of exclusivity for biologics. (Cohrs, 12/10)
Politico:
‘We Ate Their Lunch’: How Pelosi Got To ‘Yes’ On Trump’s Trade Deal
Some issues were worked out quickly: An agreement to strip out protections for biologic drugs, which opponents say would allow drug companies to keep prices high, was struck in those first few weeks, said Rep. Earl Blumenauer (D-Ore.), who focused on the issue for the working group. It was deliberately kept under a proverbial lock-and-key to help prevent a propaganda campaign from the powerful pharmaceutical lobby, which could have derailed the handshake deal. The early win for Democrats boosted members’ confidence and showed the administration was willing to make concessions. But compromises on other areas — specifically, labor and enforcement provisions — remained elusive. The caucus began to splinter over summer recess as moderate Democrats grew increasingly anxious to hold a vote on the agreement. (Cassella, 12/10)
The Washington Post:
With USMCA And Parental Leave, Democrats Say They Won Big Concessions From Trump
Democrats have emphasized that they won inclusion of new protections for workers’ rights and scrapped part of the initial agreement that would have raised prescription drug prices. “The same Republicans who are complaining they are not included are also too scared to vote against [Trump]. So why would he bother negotiating with them?” said an aide to a GOP senator, speaking on the condition of anonymity to discuss caucus dynamics. (Kim and Stein, 12/10)
The Hill:
Democrats Declare Victory For Eliminating Drug Protections In Trade Deal
House Democrats are taking a victory lap after getting rid of controversial protections for biologic drugs in the new North American trade agreement. House Democrats and the White House on Tuesday announced a deal on a trade pact to update the North American Free Trade Agreement (NAFTA), securing a major legislative goal for both Democrats and President Trump. (Weixel, 12/10)
Stat:
With New Trade Deal, Trump Deals A Blow To Drug Makers
“The real losers today are America’s scientists, entrepreneurs and patients waiting for the next generation of breakthrough medicines,” said Jim Greenwood, CEO of the Biotechnology Innovation Organization, which represents many biologic manufacturers. “They have forsaken a sector in which America leads the world.” Privately, lobbyists had even harsher words for the Trump administration. “This was a reflection of the weakness of the negotiating skills of the president and his team,” said one lobbyist, who added that this was the worst-case scenario for drug makers. “This was an unforced error and very, very weak negotiating.” (Florko, 12/10)
In other pharmaceutical news —
Bloomberg:
Drug-Plant Inspections Ebbed As Tainted Pills Flowed To U.S.
Inspections of foreign drug manufacturers by the U.S. Food and Drug Administration have fallen in recent years despite increasing worry about the safety and quality of generic medications, congressional investigators said. FDA inspections of overseas pharmaceutical manufacturers declined 10% from 2016 to 2018, according to a report by the Government Accountability Office, in part because the agency has fewer inspectors and has struggled to fill open jobs abroad. The number of domestic drug-plant inspections dropped 13%. (Annett, Cortez and Lee, 12/10)
