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Pink Sheet – Biomedical Reform Legislation May Be Piecemeal But Holistic

Pink Sheet – Biomedical Reform Legislation May Be Piecemeal But Holistic

21st Century Cures Initiative – House Energy and Commerce Committee’s FDA, healthcare reform initiative – gets praise for its all-encompassing assessment of biomedical innovation process, but necessary legislative fixes may not come all at once.

BOSTON – The House Energy and Commerce’s 21st Century Cures Initiative may be more likely to produce a variety of separate legislative solutions to modernize and accelerate U.S. biomedical innovation rather than one large bill, a committee member and a key pharma stakeholder indicate, while others question whether the process will result in any unique legislation at all.

Regardless of a singular legislative finale or not, multiple parties seem to agree that the process has kicked off an important change in how biomedical innovation is tackled by Congress: by considering all phases of medicine from discovery through patient delivery and payment in one process, the 21st Century Cures Initiative is helping break down silos in the healthcare space.

Vice Chairman of the Energy and Commerce Health Subcommittee Michael Burgess (R-Texas) said that as the 21st Century Cures Initiative heads towards legislation he prefers “multiple bills to big bills.”

“Let’s try to not fix everything at once,” Burgess told “The Pink Sheet” DAILY Aug. 25.

This sentiment was also echoed by Pfizer Inc.’s Senior Director for Advocacy & Professional Relations Robert Popovian. “I don’t think you are going to see all-encompassing legislation, let’s put it up front. I think you are going to see bits and pieces of work,” he said in an interview.

Popovian said there may be “fixes” made to “macro level” issues that have been hanging around for a while as well as new solutions that could “really kick start innovation.”

“For example, fixing [Medicare’s sustainable growth rate] may not be necessarily ‘fixing’ the SGR; it may be fixing the way we reimburse for healthcare in the United States and developing, for example, quality measures is a big component of what innovation is all about.”

Popovian said he expects there to be “a slew” of legislative proposals next year, but added that he hopes “this is a much longer discussion that occurs over a period of time,” because as science evolves the polices that govern science need to as well.

“We cannot just have this snapshot of legislative efforts and then let’s put it aside and let’s run to something else. I think this is a longer-term issue that we need to deal with,” Popvian said.

Election Will Not Squash Effort

Burgess and Popovian both spoke in Boston Aug. 25 at a Tufts Center for the Study of Drug Development, Manhattan Institute forum designed to coincide with Energy and Commerce’s cures initiative, bringing together policymakers, patient advocates, academics and industry experts to assess roadblocks to bioinnovation and explore ways to create a better paradigm for the discovery, development and delivery of new medicines to patients (“Congress Dives Into Biomedical Innovation: Will It Drown In A Deep Sea Of Competing Needs?” — “The Pink Sheet,” May 12, 2014).

The lawmaker emphasized that this is a listening and a learning period and that there is not likely to be any legislation surrounding the cures initiative this year.

Burgess was confident the 21st Century Cures effort will continue past the November midterm elections, adding that he does not expect the Energy and Commerce Committee structure to change substantially, except for the departure of the full committee’s ranking minority member Henry Waxman (D-Calif.), who is retiring (“Waxman’s Congressional Exclusivity Set To Expire, But There Will Be No Equivalents” — “The Pink Sheet,” Feb. 3, 2014).

A main priority after election season will be getting partners in the Senate, Burgess told “The Pink Sheet” DAILY. He said one of the reasons the Senate hasn’t been involved the process thus far is because the House is late it its election cycle.

Full Energy and Commerce Chair Fred Upton (R-Mich.) kicked off the 21st Century Cures Initiative in early May, along with Democratic counterpart Diana DeGette (D-Colo.), though the Health subcommittee under the leadership of Joe Pitts (R-Penn.) has since led much of the discussion (“Where’s Upton? 21st Century Cures Take Temporary Back Seat To The Internet” — “The Pink Sheet,” May 26, 2014).

Jeff Allen, Friends of Cancer Research executive director, said in an interview that the push behind the initiative is coming from top leadership in the Energy and Commerce Committee and that momentum isn’t fading.

“You know Chairman Upton has made this his key priority. He’s very passionate about it, he’s shown this not only in the time that the committee has put forth to discussing this but even when given the opportunity to hear him speak about this personally it’s clear that this is a personal priority for him.”

Attempts To Minimize Controversy

Allen said he believes the hope is to have discussion drafts available by the end of this year or early next year. The post the midterm electronic season should allow Congressional staff members time to “put pen to paper and lay out what their game plan is.”

Unlike Burgess and Popovian, Allen envisioned a singular, but multi-part bill.

“I would imagine with the diversity of topics that they are hearing about that it would have to be kind of a multi-part piece of legislation and I think their hope is to address different points along the continuum of drug development and delivery. So there may be underlying laws that they are looking to make adjustments [to] that they’ll have to address in different sections of a bill I would imagine. But I think the goal would be to try and wrap it into some sort of singular package if possible and I think they are trying to limit the controversial items that would get included.”

Allen said that given the limited legislative calendar, passing one bill versus 10 should be an easier feat.

And though the committee is tackling multiple topics he said many of them are “intricately woven together” noting there will likely be “be many different interdependent ideas in order to really achieve the goals the committee is trying to achieve.”

All Encompassing Nature Gets Praise

One person who doesn’t expect the 21st Century Cures Initiative to result in anything more than ideas for the next prescription drug user fee cycle was Tuft’s CSDD Director Ken Kaitin.

“The 21st Century Cure to me is just a call for ideas. I’m not sure there is anything more going on there,” Kaitin said.

“One of probably the greatest achievements of the user fee legislation is the ability to affect FDA reform every five years. So I don’t see anything happening between now and the next five year period,” he said, but added that it is a “great time” to start preparing for the 2017 user fee reauthorization.

Kaitin did not dismiss the effort, noting that what “may be the most important aspect of all of this” is that the initiative brought together stakeholders that don’t normally play a role in the user fee process, addressing the broader needs of the healthcare system.

“The landscape for innovation is changing dramatically. … When they passed the first user fee legislation in 1992 there were the regulators and there were the developers, the drug sponsors. Now everything is a consortium of some sort to bring products, it’s a partnership model and we’re moving more and more in that direction,” Kaitin said.

“Any initiative that’s going to try to improve the facility to get drugs on the market is going to have to encompass those stakeholders in a way that didn’t exist in the past and that’s why these types of discussions are so important. It’s not just industry and the FDA, it’s now payers involved, it’s the venture capital, it’s the outsourcing, contract research organizations, all of these entities are going to have to be brought into the picture,” Kaitin said.

“And even this discussion about big data suggests that there is a whole other industry out there that is probably going to be pivotal. They may not be pivotal yet but they are going to be pivotal because they are making a lot of noise,” he said.

“So I think part of these discussions is weighing the fact that it’s no longer just these two stakeholders, it multiple stakeholders that are going to be necessary for moving products forward and that is going to have to be reflected in any kind of reform efforts going forward,” Kaitin said.

Pfizer’s Popovian expressed similar sentiment, praising the recognition by policy makers of the complex landscape and moving beyond the typical questions of FDA reform or NIH funding. Broadening discussions to include reimbursement, medical access and even medication adherence is “the biggest thing” that Pfizer will get out of the 21st Century Cures process.

“It’s heartwarming to see that they are actually taking a global view of this thing, rather than a siloed very short term view of trying to fix something,” Popovian said.…