Life Science Compliance Update

February 28, 2017

Trump Executive Order Targets Regulations

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On one of his first few days on the job, President Donald Trump signed an executive order that would require all government agencies to eliminate two regulations for every one new regulation instituted.

The order was characterized by the Administration as a plan to help benefit small businesses. However, it is likely to have an impact on the United States Food and Drug Administration (FDA) as it applies to every agency (other than those related to military or national security), or any other agencies exempted by the Office of Management and Budget (OMB).

How this plan will work for an agency like the FDA is hard to comprehend: most of the regulations are intertwined with one another. As the EO is written, if the agency needed to put in place a new regulation, it would then have to presumably cut out two other, unrelated regulations that are linked to public health.

Another problem is that, according to the text of the EO, the directions apply to FDA guidance documents as well. This will be a large problem for pharmaceutical and medical device companies that rely on such guidances to understand FDA’s interpretations of the law. The EO defines the term ‘regulation’ or ‘rule’ to mean “an agency statement of general or particular applicability and future effect designed to implement, interpret, or prescribe law or policy or to describe the procedure or practice requirements of an agency.

The way this EO is implemented across the federal government is going to come largely from the OMB director, who will provide the heads of agencies with guidance addressing, among other things, “processes for standardizing the measurement and estimation of regulatory costs; standards for determining what qualifies as new and offsetting regulations; standards for determining the costs of existing regulations that are considered for elimination; processes for accounting for costs in different fiscal years; methods to oversee the issuance of rules with costs offset by savings at different times or different agencies; and emergencies and other circumstances that might justify individual waivers of the requirements.” 

Prior to releasing this EO, President Trump said, “This will be the biggest such act that our country has ever seen. There will be regulation. There will be control. But it will be normalized control where you can open your business and expand your business easily.”

"If you have a regulation you want, No. 1, we're not going to approve it because it's already been approved, probably, in 17 different forms," Trump said from the White House. "But if we do, the only way you have a chance is we have to knock out two regulations for every new regulation."

Although many of Trump's other executive orders have been met with criticism, this latest policy is not unfounded. Back in 2010, the United Kingdom adopted a similar policy, though its implementation did not apply to taxes, certain European Union legislation, non-business regulations and "regulation for civil emergencies," according to the U.K. government.

OMB Issues Guidance

On February 2, 2017, the OMB did issue guidance to the Agencies, highlighting what to expect and how to handle this executive order. The Q&A offers some clarity and boundaries for the EO signed last Monday, noting: “The EO’s requirements for Fiscal Year 2017 apply only to those significant regulatory actions, as defined in Section 3(f) of Executive Order 12866, an agency issues between noon on January 20 and September 30, 2017.”

But the OMB guidance does offer some wiggle room for FDA in terms of issuing draft or final guidance (2017 guidance plans for FDA's Center for Drug Evaluation and Research are here) noting that “significant guidance or interpretive documents will be addressed on a case-by-case basis.”

As far as what existing regulations if repealed would be considered part of the “two out” part of the EO, OMB notes, “Any existing regulatory action that imposes costs and the repeal or revision of which will produce verifiable savings may qualify.”

The guidance also offers FDA, which is an agency that deals with public health and safety, some ways to waive the “two out, one in” requirements of the EO. “Emergencies addressing critical health, safety, or financial matters, or for some other compelling reason, may qualify for a waiver from some or all of the requirements of Section 2,” the guidance notes.

But if a new regulation is implementing a new law from Congress (for instance, with FDA’s pending implementation of the 21st Century Cures Act), OMB clarifies that agencies should still “identify additional regulatory actions to be repealed in order to offset the cost of the new significant regulatory action, even if such action is required by law.”

February 27, 2017

FDA’s Meeting on Promotion - Can We Glimpse the Future?

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In November, the FDA held a two-day Town Hall meeting to allow for input from stakeholders and patients surrounding agency regulation of manufacturer communications regarding unapproved uses of drugs and medical devices. This article provides a brief summary of the two-day event, including several presenters and their opinions.

It is no secret that ever since the Coronia case, the United States Food and Drug Administration (“FDA”) has been working on a comprehensive review of the regulatory framework related to firms’ communications about unapproved uses of approved/cleared medical products. These are products that are approved to be marketed for a particular use, but physicians and healthcare professionals have discovered other uses for the product that the FDA has not approved (e.g., unapproved use). The question dogging the FDA is whether a manufacturer may legally discuss the unapproved use with healthcare professionals beyond merely responding to a question if the information being imparted is both truthful and not misleading.

Read the full article in the February 2017 issue of Life Science Compliance Update

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February 24, 2017

Medical Device Parallel Review Program Made Permanent

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A few months back, the U.S. Food and Drug Administration and the Centers for Medicare & Medicaid Services announced they are making permanent their “Program for Parallel Review of Medical Devices,” which is now operating as a pilot program.  The parallel review initiative allows concurrent FDA and CMS review of a medical device with the goal of reducing the time between FDA marketing approval or granting of a de novo request and Medicare coverage decisions, thereby “facilitating earlier access to innovative medical technologies for Medicare beneficiaries.”

Announcement of Extension

In the notice announcing the extension of the parallel review program, the agencies observe that the pilot program benefitted manufacturers by providing feedback to help design pivotal trials that can answer both agencies’ evidentiary questions. The notice also cites the program’s success in facilitating issuance of a Medicare national coverage determination less than two months after a medical technology received FDA premarket approval. The agencies are soliciting nominations from manufacturers of additional innovative medical devices to participate in the parallel review program. However, the agencies will only accept five candidates per year.  

Federal Register

In the official announcement, FDA and CMS describe the Parallel Review program is a collaborative effort that is intended to reduce the time between FDA marketing approval or FDA’s granting of a de novo request and Medicare coverage decisions through CMS’s National Coverage Determination (NCD) process. This program is intended to ensure prompt and efficient patient access to safe and effective and appropriate medical devices for the Medicare population

Parallel Review allows both FDA and CMS to review information about a medical device concurrently, rather than sequentially, while continuing to make their premarket review and coverage decisions consistent with their respective statutory authority. FDA works to ensure that only safe and effective medical devices are marketed in the United States. CMS makes coverage decisions for medical technologies, which are reasonable and necessary for the Medicare population. Neither FDA’s premarket review criteria nor CMS’s coverage processes criteria change when a medical device is accepted into the parallel review program.

Lessons Learned From the Parallel Review Pilot Program

The FDA and CMS write that they learned two primary lessons from the Parallel Review pilot program. First, they found that manufacturers benefit from engaging both Agencies at the pivotal clinical trial design phase. The feedback that manufacturers receive from both Agencies at the pivotal clinical trial design stage can assist manufacturers in designing pivotal trials that can answer both Agencies’ evidentiary questions. Thus, it is more likely that manufacturers will only need to conduct a single pivotal clinical study rather than several pivotal clinical studies to satisfy both Agencies. Second, concurrent review by the Agencies of clinical evidence can reduce the time from FDA premarket approval or the granting of a de novo request to an NCD. For example, on August 11, 2014, FDA approved a medical device that was part of the Parallel Review Pilot Program. On the same day, CMS initiated its national coverage analysis (NCA). CMS published a favorable final NCD on October 9, 2014, less than 2 months after the medical device received its premarket approval and 7 months before the NCD statutory due date.

Parallel Review Process

The program has two stages: (1) The pivotal clinical trial design development stage, and (2) the concurrent evidentiary review stage. The manufacturer should submit a request for parallel review prior to the start of the first stage by sending an email to Parallel-Review@ fda.hhs.gov, which indicates their interest in the program and includes the following information:

  1. Nomination of manufacturer:
  • Name of the manufacturer and relevant contact information;
  • name of the product;
  • succinct description of the technology and disease or condition the device is intended to diagnose or treat; and
  • state of development of the technology (that is, in pre-clinical testing, in clinical trials, currently undergoing premarket review by FDA)
  1. A statement that the manufacturer intends to meet jointly with FDA and CMS using FDA’s Pre-Submission program, or other mechanisms that allow for meetings of the three parties to gather and incorporate feedback from both Agencies about the design and analysis of their pivotal clinical trial, to support a marketing application and a National Coverage Determination.
  1. A statement that the medical device will require an original or supplemental application for premarket approval (PMA) or the granting of an FDA de novo request.
  1. The medical device is not excluded by statute from Part A and/or Part B Medicare coverage (and the request for parallel review includes a list of Part A and/or Part B Medicare benefit categories, as applicable, into which the manufacturer believes the medical device falls).
  1. A statement that the medical device addresses the public health needs of the Medicare population (and the request for parallel review includes an explanation of how).

Upon completion of the pivotal trial and submission of an original or supplemental PMA, or a de novo request, the Agencies intend to review the pivotal clinical trial evidence concurrently. Both Agencies will independently review the data to determine whether it meets their respective Agency’s standards and communicate with the manufacturer during their respective reviews.

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