- With drug pricing reform top of mind in Washington, Congress is likely to pass the CREATES Act within the next four months, one policy analyst predicted Wednesday, citing bipartisan backing.
- The bill would create a speedier and stronger legal process for generic manufacturers to challenge branded drugmakers that they claim are withholding drug samples in order to obstruct generic competition.
- While generic makers like Mylan and Teva Pharmaceutical would benefit if the bill became law, some pharmaceutical giants like Johnson & Johnson, Celgene and Novartis would be particularly affected, Andrea Harris, senior vice president of Height Capital Market's healthcare team, wrote in a Nov. 28 note.
The Creating and Restoring Equal Access to Equivalent Samples Act seeks to stop branded drugmakers that withhold samples of their medicines from generic makers in an effort to delay or prevent generics from coming to market.
The bill would legally require brands to sell "sufficient quantities" at "commercially reasonable" prices to generic competitors who need samples for bioequivalency testing as part of their Abbreviated New Drug Applications.
Additionally, the legislation would create a legal framework to provide generics with the ability to get injunctive relief quicker from courts, and allow judges to award payments to generics to deter this behavior from branded companies.
To determine branded drugmakers at an elevated level of risk, Harris cross-referenced a list of 52 medicines that generic drugmakers reported difficulty in obtaining samples of with the percentage of revenue each of those therapies produces for the branded manufacturer.
She found eight drugmakers with three or more sample inquiries for drugs that made up at least 3% of the their respective revenue: Acorda Therapeutics, BioMarin, Novartis, Celgene, Vivus, Sun Pharmaceutical, Johnson & Johnson and Gilead Sciences.
A few of these drugs were especially high sources of revenue for their manufacturers in 2017, with Ampyra (dalfampridine) making up about 92% of Acorda's, Revlimid (lenalidomide) accounting for 63% of Celgene's and Kuvan (sapropterin dihydrochloride) making up 31% of BioMarin's.
The bill needs to overcome opposition from PhRMA, the powerful branded drug lobby, which has scuttled efforts to move the bill forward before.
"We continue to work with policymakers to find a path forward to amend the CREATES Act and find a solution that preserves the U.S. Food and Drug Administration's role in the REMS process to protect patient safety and at the same time facilitates generic competition," Andrew Powaleny, PhRMA's director of public affairs, said in an emailed statement to BioPharma Dive.
Mike Brzica, vice president of federal government affairs for the Association for Accessible Medicines, the generic industry's leading trade group, said in an interview with BioPharma Dive on Wednesday that he sees the CREATES Act as the only ready, on-hand solution for Congress on prescription drug policy. His group strongly supports the bill.
Brzica said his organization is doing everything possible to move this forward in the lame duck session, but also expects to see it in play in the new Congress with a Democratic-controlled House of Representatives if it doesn't pass through by then.
Both Brzica and Harris noted the forces driving the bill toward passage. It has bipartisan support in both chambers and aligns with the Trump administration's drug pricing blueprint. It already has been reported out of a Senate committee, and the Congressional Budget Office calculated it would shave $3.8 billion off the federal deficit over a decade.
Additionally, Harris predicted the bill could be used to offset other measures Congress may take. Namely, Congress faces an April 2019 deadline if they choose to delay a $1,250 increase in out-of-pocket costs for seniors on Medicare Part D scheduled for 2020. It could also be passed alongside lowering the 70% manufacturer discount required in Part D coverage gap, or the so-called donut hole, which has been a priority of the pharma industry.