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US FDA, CMS target scores of future regulatory actions under FY'19 agenda

The Trump administration unveiled its fall unified agenda of regulatory and deregulatory actions it plans to take over the next several months, including a plethora of proposals from the U.S. Food and Drug Administration and the Centers for Medicare and Medicaid Services.

The administration also reported that it had eliminated $23 billion in overall regulatory costs across the government in fiscal year 2018 through its reform efforts.

The White House Office of Management and Budget said the administration had taken 176 deregulatory actions during the last fiscal year, 57 of which it deemed "significant."

"This is a fundamental change in direction. Agencies have actually reduced overall regulatory burdens," OMB Director Mick Mulvaney said in an Oct. 17 statement.

Health and Human Services Secretary Alex Azar said his agency had topped all others at the cabinet level in fiscal 2018 in cutting regulations, reducing the government's regulatory economic burden by $12.5 billion.

Among those eliminated were 105 different clinical measures under CMS' burden reduction initiatives "because they were unhelpful or no longer meaningful," Azar said.

CMS Administrator Seema Verma stated that her agency would "continue our efforts to eliminate unnecessary regulations that take providers away from patients and stifle innovation."

Significant regulations implemented

When asked by S&P Global Market Intelligence how many new regulations had been imposed overall by the administration during fiscal 2018, a senior White House official declined to say, only acknowledging 14 "significant" new rules completed over the year.

Four of those regulations came from HHS, including a final rule revising CMS' physician payment fee schedule and other policies for the government's Medicare Part B program, which covers injectable medicines administered in the healthcare setting for seniors and the disabled.

CMS has a number of proposals outlined in the administration's semiannual fall schedule that involve Medicare, including two more aimed at updating to the physician payment schedule and Medicare Part B for fiscal years 2019 and 2020.

Another one of the 14 regulations the administration put in place in fiscal 2018 delayed the implementation of the so-called Common Rule, the federal government's policy for protecting human subjects in clinical testing.

The Common Rule was delayed until January 2019 or until a year after that for multisite studies.

An additional regulation, however, provided researchers who receive grants from the U.S. National Institutes of Health a way to implement three of the Common Rule's provisions during the delay period.

The fourth HHS rule the administration said was significant came from the FDA, which declared certain active ingredients in over-the-counter antiseptic hand wash and other healthcare antiseptic products as not generally recognized as safe and effective.

The consumer advocacy group Public Citizen, however, said its analysis of the 14 identified regulatory actions found that "none of them can be credibly described as significantly improving the public's health and safety or saving lives."

New proposals

FDA Commissioner Scott Gottlieb has a full plate of rulemaking ahead of him, according to the administration's fall unified agenda.

Gottlieb said many of the proposals on the FDA's new regulatory schedule reflect what the commissioner laid out in January in his strategic policy roadmap, where reducing the burden of the addiction crisis, leveraging innovation and competition to improve Americans' healthcare, empowering consumers to make better and more informed decisions and strengthening the agency's scientific workforce and tools were his top priorities.

In an Oct. 17 blog, Gottlieb noted he has included more than 70 actions in his fall agenda, several of which are drug-related regulations "in support of our continued effort to advance new policies that promote beneficial innovation, modernize our programs and advance opportunities for developing more effective, targeted therapies aimed at unmet medical needs."

Among the new steps the FDA plans to take are proposals to make some drugs available without a prescription, or over the counter, Gottlieb said.

The FDA plans to propose a rule to add the common cold indication to certain OTC antihistamine active ingredients on a pilot basis.

The pilot exercise will help determine the feasibility of developing an ongoing mechanism for alignment in review and adoption of OTC drug monograph elements, the FDA stated.

The agency also plans to propose some new rules involving biologic therapies — drugs derived from natural sources, such as microorganisms or plant or animal cells.

One of those proposals could come as soon as this month, in which the FDA wants to tweak its rules to make it easier to meet a requirement under a 2010 law in which it must move biologic medicines previously approved as new drug applications to biologics licensing applications in March 2020.

Priorities and cherry pie

Among the regulations Gottlieb wants to get rid of is a rule outlining how to make frozen cherry pies — a regulation he has long-sought to eliminate.

"Frozen cherry pies are the only fruit pies on the market for which FDA currently maintains a standard of identity regulation," the proposal states. "This action, if finalized, would provide food manufacturers with greater flexibility in the production of frozen cherry pie products."

Given all the public health issues the FDA grapples with on a daily basis, ensuring the standard is met for what constitutes a cherry pie should not be consuming the agency's time, Gottlieb said during a Nov. 3, 2017, forum at the National Press Club in Washington.

In his Oct. 17 blog, Gottlieb emphasized that the fall agenda only highlighted a portion of the FDA's work overall, noting that just because something may not be included among the proposals does not mean it is not a priority for the agency.