Regulatory Transactions

From: Inside Health Policy

The Association for Accessible Medicines is calling on both FDA and the White House to pull FDA’s November 2016 draft guidance on quality metric submissions, arguing the guide runs counter to a slew of federal laws and agency regulations. In addition to its legal arguments, the generic drug trade group says the guidance is contrary to the program’s stated goals, and could lead to drug shortages, inefficient inspections and higher drug costs. . . .

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Editor’s Note: The Director’s Blog post, Planned Subjects for the 2020 Census and the American Community Survey, is available here.

From: Washington Blade

Chris Johnson

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John Thompson, director of the U.S. Census Bureau, wrote in a blog post the decision to omit LGBT questions from the annual American Community Survey was made despite a request from members of Congress.

“We carefully considered this thoughtful request and again worked with federal agencies and the OMB Interagency Working Group on Measuring Sexual Orientation and Gender Identity to determine if there was a legislative mandate to collect this data,” Thompson said. “Our review concluded there was no federal data need to change the planned census and ACS subjects.”

From: NAPA-net.org

Nevin E. Adams

Having put its proposed extension of the applicability date out for public comment, the Labor Department has submitted its final rule to the Office of Management and Budget for review.

According to an update on the OMB’s website, the final rule was received on March 28.

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From: The National Law Review

Article By James J. Plunkett | Ogletree, Deakins, Nash, Smoak & Stewart, P.C.

From: Stogie Guys

1) Tomás Regalado. . . , mayor of Miami, this week sent a letter to the director of the White House Office of Management and Budget, imploring the agency to reconsider FDA regulation of cigars in light of “the new administration and its own regulatory review and reconsideration process.” An email alert from Cigar Rights of America applauds Mayor Regalado for the letter, which calls for a comprehensive economic impact analysis, as well as a reexamination of “option two,” which would exempt premium cigars from the regulation. The letter can be read in its entirety here. . . .

From: PlanAdvisor

The long-running fight over the fiduciary rule took another (symbolic) step forward this week—but still there is little clarity as to what may unfold prior to the first deadlines in April. 

By John Manganaro

An updated landing page tracking the Office of Management and Budget’s (OMB) review of the Department of Labor (DOL) fiduciary rule, championed by former President Barack Obama but now being attacked by current President Donald Trump, shows the OMB has officially labeled the effort to halt the fiduciary regulations as “economically significant.”