In the Interpretive Rule issued on July 24, 2014, HRSA narrowly interpreted the exclusion and required pharmaceutical manufacturers to provide 340B discounts to the new types of covered entities for Orphan Drugs when they are used to treat something other than the rare diseases and conditions they were developed to target. In addition, HRSA sent letters to pharmaceutical manufacturers stating that failure to provide 340B discounts to eligible 340B covered entities for non-orphan uses would be deemed a violation of the statute. The lawsuit challenged HRSA’s interpretation, arguing that the orphan drug exclusion must apply to Orphan Drugs regardless of their particular use. The Court denied HRSA’s motion for summary judgment and granted PhRMA’s motion for summary judgment because it determined HRSA’s Interpretive Rule was contrary to the plain language of the statute. … [Read more...] about D.C. District Court Vacates HRSA’s Interpretative Rule on Orphan Drugs
FDA has recently partnered with PatientsLikeMe, an online patient networking forum, to leverage patient-reported information to bolster its drug safety monitoring efforts. PatientsLikeMe, with its 350,000 members representing over 2,500 health conditions, has collected more than 110,000 adverse event reports on 1,000 different drugs. This partnership, which is in the form of a research collaboration agreement , will provide FDA with access to “real-world” data about patients’ drug and disease experiences (the information provided to FDA is anonymous; so it does not appear, at least at this time, that FDA would be able to follow up with patients who post on the forum). More broadly, this partnership is evidence of increasing interest, among both regulators and pharmaceutical manufacturers, in the value of social media as a tool to identify potential adverse drug reactions and safety issues. … [Read more...] about FDA Leverages Patient-Reported Information to Monitor Drug Safety
The nature of this debate will largely hinge on how pioneering reforms play out in the market. If the new California law succeeds in promoting access to specialty drugs without destabilizing insurers’ ability to manage prescription drug costs, then other states may follow suit with legislation addressing cost-sharing. But if the law and similar reforms prove ineffective in stemming the negative impacts of drug prices, lawmakers may resort to more radical measures and industry mandates. … [Read more...] about California Imposes Controversial Cost-Sharing Restrictions to Facilitate Patient Access to Expensive Drugs
Employers, however, must treat positive tests for marijuana cautiously. Decisions in California, Colorado, Montana, Oregon, and Washington collectively provide support to take adverse action against employees who use marijuana, recreationally or medicinally, and may suggest that such employer-favorable rulings will issue even from courts reviewing state statutes providing employment protections. Thus, a bright-line approach to discharging or refusing to hire marijuana users may be defensible related to marijuana use. But given the uncertain state of the law, employers should consider taking the following steps to reduce potential liability: … [Read more...] about Marijuana in the Workplace: The Growing Conflict Between Drug and Employment Laws
In it, Biogen Idec provides a detailed overview of the manufacturing process for the recombinant hemophilia treatment intended for a direct to consumer audience. In a therapeutic area in which traditional blood derived clotting factors may give rise to infection risk, the manufacturing process for this recombinant alternative may be a key differentiator for patients. While the video is educational in tone and does not make claims about the efficacy or relative safety of the product, the four and a half minute video includes robust disclosures of the product’s indication and risks. It is a terrific example of the creative ways in which manufacturers may be able to use Twitter’s video capabilities to escape the strict 140-character limit, allowing them to produce compliant promotional communications for use in this medium. Up next from Elocatate’s Twitter account as the company continues to test the waters –patient testimonial videos. … [Read more...] about Will Promoted Video Pave the Way for Drug and Medical Device Promotion on Twitter?