Posted by William P. Conaboy Jr.
on August 15, 2012
President Obama recently signed a bipartisan bill that authorizes Food and Drug Administration (“FDA” or “Agency”) user fees for five more years and establishes new user fees for the FDA’s review of generic drugs and biosimilar products. The bill reauthorizes the Prescription Drug User Fee Act (“PDUFA” or the “Act”), a law originally passed by Congress in 1992. PDUFA permits the FDA to collect user fees from drug manufacturers to fund, among other FDA endeavors, new drug and medical device approval. The most recent reauthorization of the bipartisan bill, which increases the amount of money drug and device manufacturers must pay the FDA to review a new drug or device application, has gained the support of both Congress and the pharmaceutical industry.
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Tags: FDA, Pharmaceutical, Pharmacy
Posted by Judy Mayer
on August 01, 2012
Fraud and Abuse
Every day Groupon, Living Social, Buy With Me, and a host of other social coupon websites flood the inboxes of millions of consumers with daily deals. These websites offer discounts on a variety of products and services, and are extremely popular among restaurants and businesses for their ability to bring in new customers and generate revenue.
But what if the deal is for a dental exam, laser vein removal, or Botox® treatments? The general public probably doesn’t care about the ramifications of using social coupons for health care services, because, let’s face it, everyone likes a great deal. Health care providers, however, definitely should.
Why? Because, depending on the nature of the daily deal, a health care provider who offers a discount through these types of social coupon websites could be violating federal and/or state laws. Continue reading…
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Tags: Anti-Kickback Statutes, Fee-Splitting