On Wednesday, October 14, 2015, the U.S. District Court for the District of Columbia (the “Court”), Judge Rudolph Contreras, vacated the Health Resources and Services Administration’s (“HRSA”) interpretive rule on Orphan Drugs (“the Interpretative Rule”) as “arbitrary, capricious, an abuse of discretion, or otherwise not in accordance with law.” As a result of the ruling, pharmaceutical manufacturers are not required to provide 340B discounts to certain types of covered entities for Orphan Drugs, even when the drugs are prescribed for uses other than to treat the rare conditions for which the Orphan Drug designation was given. This issue has been the subject of long and protracted litigation including a previous court ruling that invalidated HRSA’s Final Rule on Orphan Drugs because HRSA lacked the authority to promulgate the rule. [HRSA Issues Interpretive Rule on 340b Orphan Drug in Response to … [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.Postmarketing surveillance focuses on tracking the safety of drugs once … [Read more...] about FDA Leverages Patient-Reported Information to Monitor Drug Safety
In response to public discontent over surging drug prices, federal and state lawmakers are scrambling to introduce drug price reform legislation. While many of these reforms have targeted drug manufacturers, a few state legislatures have considered bills that would impact insurers’ ability to shift excessive drug costs to their insured enrollees. Most notably, California recently adopted legislation that will cap copayments for outpatient prescription drugs offered by commercial insurers in the general market and under the state’s health insurance exchange. Industry stakeholders will be closely monitoring this novel legislation in the Golden State for its potential impact on future drug pricing reforms.On October 8, 2015, California Governor Jerry Brown signed Assembly Bill 339, which will require insurers to limit copayment amounts to $250 for a single 30-day outpatient prescription and $500 for enrollees with high-deductible plans. The new law, which becomes effective … [Read more...] about California Imposes Controversial Cost-Sharing Restrictions to Facilitate Patient Access to Expensive Drugs
Despite the growing number of states that have legalized the use of marijuana, the drug remains illegal under federal drug laws. The legal landscape is made more confusing when considering the differing levels of employment protection that these state laws offer to marijuana users. With this patchwork of state laws, employers are left to grapple with whether and how to accommodate their employees who use marijuana for medical purposes or for off-duty personal consumption. The Legal Landscape Twenty-three states and the District of Columbia have legalized medical and/or recreational use of marijuana. These jurisdictions provide marijuana users with varying levels of protection against employment discrimination. The majority—Alaska, California, Colorado, Georgia, Hawaii, Maryland, Massachusetts, Michigan, Montana, New Jersey, New Mexico, Oregon, Vermont, and Washington—merely decriminalize use. Other jurisdictions—Arizona, Connecticut, Delaware, the District of … [Read more...] about Marijuana in the Workplace: The Growing Conflict Between Drug and Employment Laws
When FDA published its draft guidance Internet/Social Media Platforms with Character Space Limitations— Presenting Risk and Benefit Information for Prescription Drugs and Medical Devices in June 2014, I, like many others with an interest in pharmaceutical and medical device promotion, believed that the issue of social media promotion of drugs and medical devices was largely settled. Even with the limited concessions offered by FDA to reduce the traditional risk disclosure requirements, absent a substantial shift in FDA’s position, Twitter was not going to be a medium that drug and device companies could use to effectively promote their products. Sure, companies could use Twitter for corporate communications, disease awareness messaging and reminder ads that didn’t mention products’ indications, but promotional claims for products appeared to be off limits. Only the simplest and lowest risk drugs and medical devices could possibly meet the standards for … [Read more...] about Will Promoted Video Pave the Way for Drug and Medical Device Promotion on Twitter?