Orthopedics This Week | February 14, 2017 - Page 22
ORTHOPEDICS THIS WEEK VOLUME 13 , ISSUE 5 | FEBRUARY 14 , 2017 22 ticularly as most regulations are not necessarily intertwined . So if the agency needed to put in place a new regulation , it would then have to presumably cut out two other , unrelated regulations linked to public health .
“ According to the text of the EO , this plan will likely apply to FDA guidance documents too , which will be a problem for pharmaceutical and medical device companies that rely on such guidance to understand how FDA interprets the law .”
For example , noted Brennan , if the FDA wanted to finalize guidance on how companies can use multiple endpoints in clinical trials , the agency would then presumably have to identify two other regulations unrelated to clinical trials that it would need to eliminate . And those decisions on what to cut and what to add would also be reviewed by the White House , according to officials , who added that the new EO sets a budget of $ 0 for new regulations in 2017 .
On whether the EO applies to FDA guidance documents , a White House spokesman told Brennan via email : “ A guidance from OMB is forthcoming .”
The OMB Director will issue , “ 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 .”
FDA Hiring Freeze and Industry Fees
As the FDA figures out if it will be exempt from the new “ one in , two out ” rule , industry regulatory leaders will be doing their best to recast the industry ’ s importance as a national security or public safety concern after a Trump hiring freeze was announced . How will that freeze impact FDA officials hired from user fee funds collected from industry ?
The White House told Brennan , “ The fact that FDA is funded by user fees does not in and of itself exempt the FDA from being subject to the Hiring Freeze Memorandum since the hiring freeze applies to all executive departments and agencies regardless of the sources of their operational and programmatic funding . That said , the FDA ’ s user fee supported work could be subject to public safety and national security exemptions provided for by the memorandum .”
Radio Silence With Congress
Meetings between FDA and congressional staffers on the user fee agreements have reportedly had to be cancelled as the Trump Administration has called on agencies to halt all correspondence with Congress .
Michael Gaba , a life science partner at Holland & Knight law firm , reportedly said Trump ’ s executive order was broadly written and gives the director of the OMB latitude in how to implement it .
“ There is discretion on how you evaluate the cost of old and new regulations ,” Gaba said . “ Before we can really analyze this we need to see what the OMB director says .”
The first three moves by the Trump White House related to medical device makers are going to take a while to digest . For now , it ’ s just plain indigestion . — WE
Spinal Injuries : New Return to Play Guidelines
Spinal Injuries in Athletes , a new reference guide from Wolters Kluwer and the American Academy of Orthopaedic Surgeons , offers guidelines on how to manage spinal injuries both on and off the field , including when athletes can return to play after specific spinal injuries .
Wikimedia Commons and Johntex
The book , according to a recent press release , will cover “ the full timeline of care — from the [ point ] of injury on the field to diagnosis , treatment , rehabilitation and return to play .”
Andrew C . Hecht , M . D ., editor of the book and a member of the NFL Brain and Spine Committee and chief of spine surgery for the Mount Sinai Health System in New York City , told OTW that Spinal Injuries in Athletes is not a howto guide on performing spinal surgery . Instead it focuses on practical issues like how to place an injured player on a backboard to carry them off the field , or whether or not the injured player ’ s helmet should be removed .
Both surgical and non-surgical treatment and rehabilitation plans will be discussed for common injury patterns that affect the cervical and lumbar spine including stingers / burners , cer-