The National Association of Chain Drug Stores asks the Internal Revenue Service to clarify health care reform law regulations so flexible spending and health reimbursement accounts can be used for OTC drug purchases where pharmacists validate a prescription at points of sale. The group's Oct. 19 letter also says in the event IRS does not clarify the FSA/HSA use for OTCs, the agency should delay the effective date of the provisions longer than the proposed two-week delay. The provisions are among the Patient Protection and Affordable Care Act components effective Jan. 1, 2011. The act limits OTC purchases with FSA and HSAs to those prescribed by doctors (1"The Tan Sheet" March 29, 2010). NACDS says a delay also is needed to make pharmacy dispensing systems and the Inventory Information Approval System, a network for retailers that accept FSAs and HSAs, agree on which drugs the act allows for purchases with the accounts
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Advanz Pharma would have had to show that the European Commission’s decision to revoke Ocaliva’s conditional marketing approval risked causing serious and irreparable harm, according to lawyers from Van Bael & Bellis.
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A new pilot aims to take Brazil closer to ‘digital transformation.’
President Trump’s new Executive Order on drug pricing reprises several policy themes from his first administration, including giving the FDA many tasks intended to increase competition in the marketplace.
FDA Commissioner Martin Makary will give industry a new avenue for access and influence despite his and HHS Secretary Robert F. Kennedy Jr.’s claims that the pharma-FDA relationship is too cozy.
The European Medicines Agency’s chief medical officer Steffen Thistrup argued that patients are able to understand the “complex regulatory and scientific issues” that the EMA committees discuss when they assess drugs.
