From: Financial Times
April 19, 2017
April 5, 2017
FDA Pleases No One With Final Guidance On Naming of Biologicals and Biosimilars
From: P&T Community
Stephen Barlas
The Food and Drug Administration (FDA) has put one more piece of the biosimilar puzzle in place by issuing final guidance on naming of biological innovator products and bio-similars.1 The agency hewed close to the thinking it first noted in an August 2015 proposed rule and guidance that would “name” a biosimilar by using its non-proprietary name separated from a random four-letter suffix by a hyphen.2,3 That format satisfied almost no one, and brand-name and generics manufacturers, as well as pharmacy groups, got almost none of the changes they requested.
March 31, 2017
Association for Accessible Medicines To OMB: Quality Metrics Guide Violates Laws, Against Program’s Purpose
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The Association for Accessible Medicines is calling on both FDA and the White House to pull FDA’s November 2016 draft guidance on quality metric submissions, arguing the guide runs counter to a slew of federal laws and agency regulations.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. . . .
Read Complete Article (Paywall)
March 30, 2017
Census Bureau: LGBT omission the result of ‘no federal data need’
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.”
March 29, 2017
DOL Submits Fiduciary Delay Final Rule to OMB
From: NAPA-net.org
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.
March 24, 2017
Trade Associations Ask OMB to Review EEO-1 Pay Data Report
From: The National Law Review
Article By James J. Plunkett | Ogletree, Deakins, Nash, Smoak & Stewart, P.C.
Over the last couple of weeks, much of the media in Washington, D.C., has turned its attention to the new director of the Office of Management and Budget (OMB), former South Carolina congressman Mick Mulvaney. This is because Mulvaney is in charge of advancing the administration’s first federal budget proposal, as well as coordinating Republicans’ efforts to dismantle the Affordable Care Act (ACA). What goes unnoticed, however, is that Mulvaney and his office will play a crucial role in the employer community’s efforts to ease the regulatory burdens that have piled up over the last several years. Here’s just one way how.
March 21, 2017
Mayor Implores OMB to Reconsider FDA Regs
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. . . .
March 2, 2017
OMB Labels Fiduciary Regulations ‘Economically Significant’
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.”
February 28, 2017
Trump issues executive orders on HBCUs, environmental regulations
From: CBS News
By
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The White House Initiative on Historically Black Colleges and Universities was started by President Jimmy Carter, but the Trump administration says the office has “lost track because they didn’t have the full force of the White House behind it.”
Mr. Trump, who is expected to list campaign promises he has fulfilled and executive orders he has signed during his first Presidential address, will also sign an executive order that will instruct a review of the Waters of the U.S. Rule (WOTUS) by the Environmental Protection Agency (EPA) and U.S. Army Corps of Engineers.
February 24, 2017
For fisheries regulations, a Trump edict signals uncertainty
From: Portland Press Herald
There’s some dispute about how routine rules would be affected, but larger actions would be all but undoable under the presidential executive order.
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However, on Feb. 2 the acting head of OMB’s Office of Information and Regulatory Affairs issued an advisory memo that clarified that the president’s order applied only to “significant regulatory actions” as defined under a 1993 executive order issued by President Bill Clinton. The memo is posted at the White House’s website, suggesting it has presidential approval.