AG/FDA Blog

Consumer-Directed Promotions About Prescription Drugs: A Look Back at Print and TV Communications

OFW Law Celebrates 35 Years of Successes in Drug/Healthcare Privacy Practices (Part VI) By Tish Eggleston Pahl In celebrating 35 years of practice, OFW Law’s Drugs, Biologics, and Controlled Substances and Healthcare Privacy practice groups are ta… Read More
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Thirty Years of Hatch Waxman

OFW Law Celebrates 35 Years of Successes in Drug/Healthcare Privacy Practices (Part I) Since its inception in 1979, OFW Law’s Drugs, Biologics, and Controlled Substances and Healthcare Privacy practices have focused on myriad regulatory issues aris… Read More
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HIPAA, the TCPA and Robodialing

Over the past several months, we have received several questions regarding how HIPAA interacts with the FCC’s implementation of rules under the Telephone Consumer Protection Act (TCPA).  Specific questions center around when authorization may be r… Read More
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And They’re Off! FDA Wastes No Time in Implementing its New Compounding Authority

It appears that FDA, like many of us, anticipated the passage of the Drug Quality and Security Act (DQSA) (H.R. 3204).  We previously blogged about Title II of the DQSA here, which focused on drug supply chain security.  Title I, the Compounding Qu… Read More
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FDA Margin Call On Off-Label Promotion

FDA’s Office of Prescription Drug Promotion (OPDP) just issued a warning letter to the CEO of Aegerion Pharmaceuticals Inc. (Aegerion) for making unapproved drug claims during two television interviews on CNBC.  FDA says Aegerion CEO, Marc Beer, o… Read More
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HITECH First Amendment Challenge Delayed – HHS Promises Guidance and Agrees to Limited Enforcement Delay

The Department of Health and Human Services (HHS) revealed in court filings yesterday that it expects to issue guidance regarding prescription refill reminder programs before September 23, 2013.  It also stated that it will not enforce the restricti… Read More
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HHS’s Updated Medical Privacy Rules Under HIPAA Could Be Susceptible to First Amendment Challenge

On January 17, 2013, the U.S. Department of Health and Human Services (HHS) issued a long-awaited pre-publication copy of revisions to the federal medical privacy requirements commonly referred to as the HIPAA Privacy Rule.  The final rule, issued p… Read More
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OFW Law Drug and Health Care Privacy Practices

OFW Law’s Drug and Health Care Privacy Practices focus on advising our clients regarding every aspect of the regulatory process related to bringing a product to market, post-marketing compliance, and issues central to the privacy of personal health… Read More
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