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Supreme Court Rules that SEC and Potentially Other Agencies Cannot Impose Civil Penalties in Administrative Proceedings
…a statute that created a federal regulatory regime to promote safe working conditions which created a cause of action not existing under common law. However, the dissent does not buy…
When FDA and the Practice of (Tele)Medicine Collide
…in compliance with the REMS provisions for these drugs. We note that FDA’s website includes numerous warnings that patients should not buy Mifeprex or mifepristone over the internet because doing…
FDA, Testing, and COVID-19: A “Mid-Mortem”
…laboratory). There were some limitations to the umbrella EUA; for example, it only allowed for authorization for use in moderate- or high-complexity CLIA laboratories. If companies wanted to pursue a…
Stand by Your Case? Without Standing, Supreme Court Precedent Means You’ll Have More Bad Times than Good
…allege economic injuries, like buying antibiotic-free meat to mitigate the risk of exposure to antibiotic-resistant bacteria or buying separate work clothes so that their care for infected patients does not…
Is It News? Is It Promotion? OPDP’s Latest Letter Shines a Light on Native Advertising
…as part of spon-con on local news stations, and demonstrates how his team was able to buy local news time to promote “the world’s first sexual health blanket.”) With regard…
District Court Dismisses PLAN B Case Against FDA Based on Lack of Standing and Failure to Exhaust Administrative Remedies
…a representational standing argument in their court papers based on several alleged injuries flowing from FDA’s August 24, 2006 PLAN B approval. The court did not buy the argument and…
FDA Announces a New Class-Wide REMS
…Healthcare Provider” letters to hospital Directors of Pharmacy/Administrators and to those healthcare providers who directly purchase/prescribe ESAs and ensure access to communication materials online. The most onerous part of this…
DEA Administrative Hearings: “Open to the Public” Requires Notice to the Public
…risk of diversion. For example, a pharmacy that learns that DEA has issued an OSC proposing to revoke the registration of one of its physician customers may choose to perform…
Court Enjoins Average Manufacturer Price Rule
We previously reported that two pharmacy associations were challenging the implementation of a rule promulgated by the Centers for Medicare & Medicaid Services (“CMS”) setting forth how to calculate the…
About Time: DEA Acknowledges that Long-Collected ARCOS Data is an Effective Enforcement Tool That Can Assist Manufacturers and Distributors
…specific quantity of drugs sold to wholesale distributors and the amount then distributed to each pharmacy. The DEA ARCOS Unit has routinely aggregated the data from all reports and provides…
D.C. Council Passes SafeRx Act; Requires Licensing of Pharma Detailers
On January 8, 2008, the District of Columbia Council passed the SafeRx Act of 2007 (“Act”), which requires pharmaceutical detailers to be licensed by the Board of Pharmacy. The Act…
Biosimilar Substitution Bill Opposition Strikes Gold in California: Governor Brown Vetoes the Measure
By Kurt R. Karst – On October 12th, California Governor Jerry Brown finally acted on Senate Bill 598, vetoing the measure. If enacted, the bill would have amended California’s Pharmacy Law…
FDA Grants PROP Petition (in Part), Proposes New Labeling and Requires Post-Marketing Studies for ER/LA Opioid Analgesics
…that holders conduct “a study to define and validate ‘doctor/pharmacy shopping’ as outcomes suggestive of misuse, abuse and/or addiction” that will then be used to inform the design and analysis…
Federal District Court Strikes Blow Against RICO Challenges to Drug Co-pay Coupons
By Jamie K. Wolszon & Alan M. Kirshenbaum ¬− On June 3, 2013, the U.S. District Court for the Southern District of New York ruled that a drug company co-pay…
Senate’s HELP Committee Releases Draft Compounding Legislation; Seeks Stakeholders’ Written Comments by May 3, 2013
…compounding manufacturer would have to comply with the other provisions of the legislation, and cannot be licensed as a pharmacy in any state. More specifically, under the legislation, compounding manufacturers…