Life Science Compliance Update

June 27, 2016

Senators Send FDA Letter with Concerns Over Draft Guidance Documents

Four United States senators sent a letter to United States Food and Drug Administration (FDA) Commissioner Robert Califf with concerns over the agency's apparent inability to revise, finalize, or withdraw draft guidance documents in a timely manner. The letter notes that on average, it takes between 425 and 797 days to finalize a draft guidance.

The comments echo comments that have been made at various Congressional hearings with myriad FDA officials, and stem from industry and physician complaints over the agency's use of draft guidance in carrying out regulatory responsibilities, particularly among those who "feel no choice but to follow draft guidances as if final, even if the most-up-to-date science would suggest an alternative path."

The letter comes a few months after the FDA's Center for Drug Evaluation and Research's (CDER) 2016 guidance agenda. The agenda outlined an increase in issuance of such guidance, with a total of 102 guidance documents set to be released this year. The number of planned guidance documents issued shows a steady incline: from 60 in 2013, 70 in 2014, and 90 in 2015.

The four senators, Lamar Alexander, Richard Burr, Johnny Isakson, and Orrin Hatch, take issue with the fact that on average, it takes the FDA over a year (sometimes over two years) to finalize draft guidance. Additionally, the FDA has been sending letters to industry with regard to "new thinking" by the agency that can only be found in draft guidance documents.

However, the senators did praise the FDA for using a new, more transparent website to list newly-issued guidance documents and for the withdrawal of forty-seven "outdated and unfinished" documents last May.

The bulk of the letter focused on requests by the senators, including an update on the stat that it takes between 425 and 797 days to finalize a draft guidance.

The letter also requests an updated list that identifies each draft guidance document that was published before December 31, 2015, and still is pending; an update on the plan for each Center and Office that "are continuing to work on their plan for which guidances will be withdrawn, reissued, or finalized;" whether or not the Agency plans to require Centers and Offices to systematically review guidances and withdraw, revise, or finalize those outstanding documents in a timely manner.

The letter also reiterated some concerns about how the Agency ensures that staff do not follow the guidance in the absence of any other policy or final guidance. The Agency has previously indicated that it provides initial and ongoing training for employees about how to develop and use guidance documents. The Senators asked for a "detailed description of who conducts these trainings, how frequently they occur, and the content and forum of the trainings. Please also provide copies of all training materials, including notes from presenters, slides or videos, and any review of the effectiveness of such training by the FDA or a contractor."

In a March 2015 response, the FDA stated that staff may sometimes reach the same results as proposed in a draft guidance when applying statutes and regulations, explaining that "[a] draft guidance reflects FDA current thinking, and thus also usually reflects its current interpretation of the statute and regulations." However, the Senators are a little concerned that when the FDA publishes a draft guidance, it includes a statement that the draft guidance document will represent the Agency's current thinking only "when finalized." The letter requests clarification as to whether a draft guidance which has not been finalized should be construed as expressing the FDA's current thinking.

The FDA has not yet responded to this letter. When the senators sent a similar letter in May 2014, the Agency took almost an entire year to respond, writing back in March 2015.

June 06, 2016

House Energy and Commerce Ask FDA for Update on Off Label Guidance

The House of Representatives, through the Energy and Commerce Committee, are questioning the United States Food and Drug Administration's (FDA) current approach to regulating off-label communications. Committee Chairman Fred Upton and Health Subcommittee Chairman Joseph Pitts recently sent a letter to the Department of Health and Human Services (HHS) that not only questioned the current approach, but also expressed a willingness of the Committee to work with the agency to help craft workable policy solutions.

The letter referenced "recent litigation" that has "raised significant questions about FDA's authority to restrict" certain communications made by medical product manufacturer communications, specifically "the proactive dissemination of truthful and non-misleading information that is outside the scope of a product's FDA-approved labeling."

The House leaders mentioned that while discussing the 21st Century Cures Act, the Committee was able to hear how new data and analyses on real-world usage of medical products is continuously being generated after FDA approval and they believe that ensuring physicians and others who are involved in influencing treatment decisions are informed about scientifically accurate "off label" information is critical to optimizing patient care. They noted one testimony in particular, that of a rheumatologist in July 2014, which stated, "By limiting the sharing of information, physicians are hampered in their ability to access all available sound medical evidence and firm scientific rationale necessary to treat patients with difficult problems." Mr. Upton and Mr. Pitts believe that preventing manufacturers from proactively providing such information is not only unsound public policy, but also constitutionally impermissible.

In the letter, Upton and Pitts state that ire the pharmaceutical companies are having toward the FDA for dragging its feet on new off-label marketing guidelines is misdirected. Instead, that frustration, according to Mr. Upton and Mr. Pitts, should be aimed toward the HHS. In the letter, the Representatives state,

As FDA's authorizing committee, we are increasingly perplexed by the agency's unwillingness or inability to publicly clarify its current thinking on these issues in a coherent manner. If FDA continues to remain silent, settlement agreements will be the only means by which policy is formulated—and it will be in an ad hoc manner lacking any semblance of consistency and cohesiveness. It has come to the committee's attention that such inaction may be the result of disagreements between FDA and HHS leadership. Specifically, despite being on FDA's guidance agenda since 2014, it is our understanding that HHS has not allowed FDA to issue its completed draft guidance addressing the scope of permissible 'scientific exchange.' While comprehensive guidance would be a welcome step in the right direction, we still question whether non-binding policy statements would satisfy due process concerns.

The letter continues on, stating that the Committee raised these concerns – even before Amarin and Pacira – and proposed targeted statutory changes to clarify key terms and concepts within the FFDCA to establish clearly defined ways that manufacturers could disseminate scientifically accurate information while preserving the FDAs approval standards for drugs and devices.

The letter concludes with a willingness to get creative, with the Representatives stating that "the committee is open to considering alternative approaches to address such an important issue. However, Congress needs a willing partner that will engage seriously in modernizing law to reflect the intersection of off-label use and 21st century medicine."

Upton and Pitts also attached a copy of the proposed bill to their letter. While it is impossible to know what the FDA – or HHS – is thinking, until the proposed guidelines come out, or Congress takes legislative action, pharmaceutical companies will continue to have to deal with the uncertain status quo and uncertain future.






June 02, 2016

House Ways and Means Committee Hearing on MACRA Implementation – Grave Concerns about Impact on Small Practices

The House Ways and Means Subcommittee on Health held a hearing on the implementation of the Medicare Access & CHIP Reauthorization Act of 2015 (MACRA). The hearing examined proposed regulatory efforts by the Centers for Medicare and Medicaid Services ("CMS").

Subcommittee Chairman Pat Tiberi applauded the bipartisan passage of MACRA last year in his opening statement. He stated that the purpose of the hearing was to "look closely at how these regulations match up with Congressional intent and what our Members and CMS are hearing from stakeholders as they digest the 950 plus pages of regulation."

He stated that by hosting the hearing, he hoped to gain better clarity on how the regulation will affect small provider groups versus large provider groups, and how the timing of implementation will proceed under "potentially tight" deadlines.

Ranking Member Jim McDermott was also grateful for MACRA, stating, "Thanks to MACRA, we have set Medicare on a more sustainable course that will allow us to pay for value in health care, rather than volume." He also alluded to the importance of public comment by stating, "I am confident that the administration will continue to be responsive to the needs of the public as it develops the final rule. This is an ongoing conversation. We still have more to learn as we work toward our shared goal of making the implementation of this landmark law a success."

Slavitt Testimony

In his testimony, Mr. Slavitt testified to the three guiding principles of the proposal: (1) Patients are, and must remain, the key focus. Financial incentives should work in the background and support physician and clinician efforts to provide high quality services; (2) That success will come from adopting approaches that are practice-driven. Quality measurements should reflect the needs of a diverse range of patient populations and practice types, and give physicians and clinicians the opportunity to select the elements of the program that are right for their practice; and (3) To strive to make care delivery as simple as possible, with more support for collaboration and communication through delivery system reform.

Mr. Slavitt also reiterated numerous times throughout the hearing that CMS is open to public feedback on the proposal during this initial comment period. He also focused on CMS' commitment to open and robust public discussion, mentioning that in the month of May alone, CMS has scheduled 35 listening sessions, webinars, and educational events.


Impact on Small Practices

The impact of MACRA on small practices was one of the most talked about practices. Members like Chairman Tiberi and Representative Sam Johnson spoke about feedback from their districts, and wanted to know how smaller, solo, rural practitioners will be able to succeed under the new payment models. Mr. Slavitt stated that this is one of the areas in which CMS is seeking feedback, but mentioned some aspects of the current proposal that may help. He mentioned that the proposal allows for reporting to occur through registries that small providers may already be participating in, and that small and solo practices are permitted to report in groups. Mr. Slavitt mentioned that CMS intends to accommodate as many practices as possible.

Qualifying APMs

Another much-discussed topic was what would qualify as advanced alternative payment models (APMs) under MACRA. Chairman Tiberi noted that the thresholds for qualification are "high, and set in statute." Representative Ron Kind and Representative Tom Price both mentioned instances in their districts where physicians participating in the first generation Accountable Care Organizations (ACOs) and the Bundled Payments for Care Improvement (BPCI) initiatives would would not qualify for the 5% bonus payments under MACRA. Representative Danny Davis mentioned a CMS statistic that estimates only 30,000 to 90,000 physicians will qualify for APMs under the regulations as they are currently designed.

Further Information

Even though the only testimony given at the hearing was by Andy Slavitt, the Acting Administrator for the CMS, any individual or organization may submit a written statement for consideration by the Committee, and for inclusion in the printed record of the hearing. Submissions must be submitted online, and must be submitted by the close of business on Wednesday, May 25, 2016.

CMS Tip Sheet

CMS has also issued a tip sheet, "Flexibilities and Support for Small Practices," which is meant to be a CMS response and acknowledgement of the "unique challenges" that small practices with 15 or fewer clinicians face. The report followed Mr. Slavitt's testimony at the W&M hearing, where as mentioned above, small practices were of much talk.

In the document, CMS cuts some slack for practices of nine and fewer clinicians by subjecting them to only two population health measures in the quality category, compared to the required three for larger groups. Clinicians will also be afforded the choice of which measurement and reporting systems work for them, with the perk of bonus points if they participate in an APM or submit additional reporting.

The document also mentioned MACRA's budget of $100 million over the span of five years for technical assistance dedicated to practices with 15 or less clinicians, which will hopefully help those practices boost their MIPS scores and transition into advanced APMs, where financial risks and rewards can be greater.


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