Join APC for an important follow-up conference call on the ESI/Tricare clawback issue, with critical legal and advocacy information you can use. Visit http://a4pcnews.com/2020-06/apc-follow-up-briefing-call-esi-tricare-clawback for details and free registration.
FDA has withdrawn its emergency approval of hydroxychloroquine as a Covid-19 treatment. Both hydroxychloroquine and chloroquine, the agency said, are "unlikely to be effective in treating Covid-19" and have serious side effects. (https://www.statnews.com/2020/06/15/fda-revokes-hydroxychloroquine/)
Not really surprising: Covid-19 cases are surging across the country about 2 weeks after states began reopening. But total US cases are down because NY's cases are down. (https://fllw.me/2YEhJkL)
FDA has agreed to extend the public-comment period for draft GFI #256 an additional 120 days.
“It looks like a shakedown to me.” – Jeff Baird, Brown & Fortunato
Many compounders recently have received a recoupment notice from ESI regarding Tricare/CHAMPUS compounded prescriptions.… (Read the rest)
In a joint letter to OMB, organized by APC, four national pharmacy associations say FDA has underestimated the administrative burden that would be incurred by state boards of pharmacy under the recently released ‘final’ MOU on shipments of out-of-state compounded drugs.
Join APC for an important briefing on the ESI TRICARE/CHAMPUS clawback recoupment notices, tomorrow, Thursday, June 11, at 5 pm EDT. Details here: http://a4pcnews.com/2020-06/thursday-briefing-call-esi-tricare-clawbacks
Patients afraid to shake? They're not alone. Read a survey (full of charts!) of 511 infectious disease specialists to see when they "Expect to Fly, Hug and Do 18 Other Everyday Activities Again": https://nyti.ms/2AfC7R7 (Spoiler: The handshake is dead.)
Seven members of Congress have written to OMB, sharing the same concerns we have about FDA's MOU on interstate shipments of compounded drugs: That it will place a tremendous and undue burden on state boards of pharmacy. Read the letter at https://a4pc.org/Common/Uploaded files/Advocacy/2020-06-08_Letter-to-OMB-on-MOU.pdf
Safety is the #1 concern for compounding, followed by safety and safety. Pharmacy Practice News got a list of "10 New Building Blocks of Compounding Safety" from Patricia Kienle, dir. of accreditation and medication safety at @CardinalHealth. Check it out: https://fllw.me/2YlEKZG
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