The Senate is clearing the way this week for a bipartisan bill supported by insurers and provider groups that is supposed to ease generic drugs' entry into the market, although the legislation's future in the House and Senate is unclear. Senate Judiciary Chair Chuck Grassley (R-Iowa) announced Tuesday that the committee will expedite the so-called Creates Act during an executive session on Thursday. The bill would relax the regulatory process known as risk evaluation and mitigation strategies (REMS) for generic and biosimilar versions of drugs and biological products with the hope that cheaper alternatives could get expedited to the market without deterrence from branded drug companies. Democratic Sen. Patrick Leahy of Vermont has led the charge on the legislation that is opposed by many in the pharmaceutical industry. Earlier this year, the bill appeared to be advancing as a potential rider along with the budget agreement, but it was ultimately dropped. Since then, lawmakers have kept up discussions on the legislation and considered passing it along with a tweak to the provision in the Budget Act that hoists some of the costs of closing the Medicare Part D coverage gap known as the "donut hole" from drug companies. The Congressional Budget Office has projected the bill would save the government $3.8 billion and also lead to significant savings for patients and insurance companies. Lawmakers are also considering it as a potential budget offset for the opioids package, a GOP lobbyist close to talks said. The legislation has powerful backers, including the American Hospital Association, AARP, Consumers Union, Blue Cross and Blue Shield Association and America's Health Insurance Plans. Still, it is unclear whether Senate or House leadership would put it on the floor; Leahy told Modern Healthcare on Tuesday he plans to keep wrestling it forward, and he is optimistic about its odds should it get there. "We are committed to having it done, and if we can bring it to a vote on the floor no matter who lobbies for and against it, it will pass," Leahy said. "It's just getting it to the floor." Correction: An earlier version of this story misstated the CBO's latest savings score for the bill. This error has been corrected.
A bipartisan bill that intends to ease the introduction of generic drugs into the market is being prepared for both Senate and House floors. The CREATES Act is supported by both insurer and provider groups, and Senate Judiciary Chair Charles Grassley (R-Iowa) has announced that its process will be expedited by a Senate committee. At the heart of the bill is a move to relax the Risk Evaluation and Mitigation Strategies (REMS) regulation process applied to biosimilar and generic drugs and biological products. It is hoped that this move will bring about an increase of cheaper alternatives to name brand drugs. The bill’s progress is being spearheaded by Democratic Sen. Patrick Leahy of Vermont despite significant opposition within the pharmaceutical industry. The legislation was initially dropped following the budget agreement, but it has been carried along by lawmakers with only minor changes. The legislation has significant backers, including American Hospital Association, AARP, Consumers Union, Blue Cross and Blue Shield Association and America's Health Insurance Plans but it is unclear whether either Senate or House leadership would put it on the floor. The Congressional Budget Office has projected that the bill would bring about $3.8 billion in savings for the government, as well as savings for patients and insurers.