“This was a bad idea two years ago, but it’s even worse after seeing what happened. [FTC Chair] Rina Khan tried to deal with the FTC. Giving that agency greater power is the last thing this Congress should do. – Senator Mike Lee
On Thursday, the Senate Judiciary Committee passed a number of bills aimed at the pharmaceutical industry. Sen. Mike Lee (R-Utah) reiterated concerns since the bill’s introduction, but the bill passed by voice vote on a bipartisan basis with minimal debate. Here we summarize the purpose of the bill.
of Maintain access to the Affordable Generics and Biosimilars Act It targets the controversial pharmaceutical industry practice of paying generic drug manufacturers to delay market entry. The bill prohibits such transactions and presumes them to be anti-competitive unless the parties can prove otherwise. Senator Chuck Grassley (R-Iowa) and Senator Amy Klobuchar (D-Minnesota), who co-sponsored the bill, announced at a committee meeting in 2021 that the bill would be approved by the Federal Trade Commission (FTC). ) will strengthen its ability to challenge these agreements. And it strikes the right balance by allowing companies to continue to pursue contracts that do not harm competition. “The bill narrowly targets the types of settlement agreements that raise serious competition concerns,” Klobuchar said.
Senator Lee expressed some concerns about the bill at its first meeting and yesterday’s meeting, FTC v. Actavis Inc.., 570 US 136 (2013) appears to be working, stating that “as this bill appears to do, it would not be possible to fundamentally change the legal standards underlying the FTC’s current approach.” , risks upsetting the successful balance we have achieved between innovation and competition. you are working decision. ” in the meantime you are working He acknowledged that a late damages settlement could actually violate antitrust laws, and said reasonable principles should be applied in making this determination. “creates the presumption that companies illegally compensated generics or biosimilars to delay the introduction of their products to the market if certain basic criteria were met.” proposed a solution in the form of an amendment that changed the standard of evidence from the requirement of the presentation of clear and persuasive evidence to the preponderance of the standard of evidence, but it was not approved.
Lee also noted yesterday’s vote that “the FTC is already investigating and prosecuting damages that have been addressed in many bills,” and that, coupled with the recent inflation-cutting legislation, there will be a cap on the prices of various drugs. pointed out that there is ” They only add to the uncertainty.
stop stall method By allowing the Federal Trade Commission (FTC) to seek civil penalties, the Federal Trade Commission (FTC) can help deter abuse of the Food and Drug Administration’s (FDA) civil petition process. Senator Dick Durbin (D-Illinois) said at last year’s conference on the bill, “Brands and allies have filed bogus petitions making dubious claims to block the entry of generic drugs. He cited one research finding that brands filed 92% of “citizen petitions.” This is a procedure that allows citizens and businesses to petition for changes in health policy. The bill’s proponent, Mr. Klobuchar, said the law was “a narrowly calibrated solution to discourage companies from engaging in this bogus petitioning activity,” adding that it “restricts the FDA from using its resources.” It wastes FDA resources when it needs to approve a new product based on the Provide medicine and help sick people recover. “
of People’s law prescription drug prices It directed the FTC to issue a report on the drug supply chain, and the three largest pharmacy benefit managers (PBMs) — CVS, Express Scripts and UnitedHealth’s Optum — filed anti-competitive laws that drive up costs for consumers. See if you are engaging in behavior. Pharmaceutical companies have pointed to PBM as part of the problem. For example, PBMs tend to favor high-priced drugs with high rebates and do not always pass the rebates on to insurance companies. The bill also directs the FTC to make policy recommendations based on its findings.
of Affordable Prescriptions for Patient Law This will allow the FTC to reduce drug “product hopping.” “This is an anti-competitive practice in which brand manufacturers seek to extend their market exclusivity in expired patented drugs by switching doctors and patients from older versions to slightly modified newer versions,” Durbin said. Think Claritin D.” The bill would also amend the process for resolving biologics patent infringement claims, “known as the ‘patent dance,’” limiting the number of patents biologics companies could assert in infringement lawsuits. Set reasonable limits to discourage the entry of biologics. Biosimilar competition.
The bill’s sponsor, Senator John Cornyn (R-Texas), cited Humira at a 2021 conference, saying that while the drug is the subject of more than 120 different patents in the US, in Europe, patients have 5 He pointed out that he had access to two different patents. Rival since 2018.
Konin commented yesterday that he and Blumenthal have long defended intellectual property protection because it motivates people to develop new life-saving medicines. attempts to eliminate gamesmanship.
of Interagency Patent Reconciliation and Improvement Act of 2023, In line with recent USPTO efforts to strengthen collaboration with FDA, an interagency task force will be established between USPTO and FDA “for the purpose of sharing patent information and providing technical assistance.” . The bill was introduced by Senators Durbin and Tom Tillis (R-North Carolina) and co-funded by Senators Grassley, Kuhn, Welch and Feinstein.
Senator Chris Koons (D-Germany), who has been active on IP issues for years, said that when he considered many bills for 2021, he would not target the bad guys at the expense of innovation. I repeated Lee’s warning about
“I agree with the general proposition of all four of these bills…but the patent system itself protects this constitutionally created property right that I believe is critical to innovation and global competitiveness. We are also concerned that the overly aggressive use of the tools created by this law could wipe out not only the bad guys but the good guys and have unintended negative consequences, which we should avoid. We look forward to working with our co-sponsors to help.”
Maggie Hirono (D-HI), who is also actively involved in intellectual property issues, echoed Koons’ words at the time.
“The patent system is very complex and every change we make to the patent system can lead to unintended consequences. may decrease.”
Lee made it clear yesterday that he would not support passage of the bill without “substantial amendments,” but has worked with co-sponsors to allow it to pass through the committee to do so. , lamented aspects of some legislation that would give the FTC more power. Giving that agency greater power is the last thing this Congress should do.Until there is a major revision to prevent FTC overreach and unintended harm to consumers, I support its passage. you can’t. “
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