Tag: Health
Thoughts on the D.C. Pharmaceutical Detailer’s License Requirement
The District of Columbia regulates many activities that go unregulated in other jurisdictions. One example relevant to pharmaceutical companies is the requirement that in D.C., detailers must obtain a license before they may speak in person with a physician, nurse or other health professional. Pharmaceutical detailers also must undergo 15 hours of continuing education every two years and must keep records of their interactions with licensed health professionals or their employees.
The District of Columbia requires that individuals obtain a license from the D.C. Board of Pharmacy in order to engage in the practice of “pharmaceutical detailing” in D.C. See D.C. Code § 3-1207.41; 17 DCMR § 8300.1. A person is engaged in pharmaceutical detailing if, acting as a representative of a pharmaceutical manufacturer or labeler, he or she communicates in-person with a licensed health professional or a representative of a licensed … Read More »
Massachusetts Amends Its Drug and Device Marketing Law
On July 8, Governor Deval Patrick signed a bill amending the Massachusetts law regulating marketing activities by pharmaceutical and device manufacturers, one of the strictest state laws in the country.
The law previously barred pharmaceutical and device manufacturers from providing meals to health care practitioners outside the practitioner’s office or hospital setting. See 111N Mass. Gen. Laws § 2. The amendment will now permit pharmaceutical and device manufacturers to provide modest meals and refreshments outside of the practitioner’s office or hospital setting, if the meal or refreshment is furnished with a non-CME educational presentation for the purpose of providing bona fide medical information, and the meal is furnished in a venue and manner conducive to communicating information. The amendment directs the Massachusetts Department of Public Health to promulgate regulations to define “modest meals and refreshments.” Pharmaceutical and device companies, however, will … Read More »
Drinker Biddle’s Health Government Relations Team Hosting: Health Care Reform & Supreme Court Review Webinar
From Capitol Health Record: By the end of June, it is expected the Supreme Court will rule on the constitutionality of the Patient Protection and Affordable Care Act. Join us to gain a better understanding of the four questions before the Court and the political, legislative and regulatory implications of the Court’s pending decisions. Our panel also will discuss the different possible outcomes of the Court’s deliberations and their respective political and policy ramifications. Regardless of where you work or who you represent, this presentation will provide important insight and analysis to help inform your business, association, legislative and/or regulatory planning.
Register now to participate in this webinar, featuring the DBR Health Government Relations team!
U.S. clinical trial website pairing — a need for privacy safeguards
Fox Trial Finder is a welcomed initiative in ongoing efforts to facilitate clinical trial participation. In a recent interview with ABC’s Diane Sawyer, Michael J. Fox, who suffers from Parkinson’s disease, said that in addition to his support for stem cell research addressing Parkinson’s, he also supports research looking for a cure on other fronts, including drug therapies and diagnostic tests. (Article Link) Toward that end, Fox’s Foundation for Parkinson’s Research recently launched an online initiative called Fox Trial Finder. This website promotes research across the country by pairing patients with clinical trials in their areas, based on the individual’s symptom profile. The foundation’s webpage notes that 30% of all clinical trials fail to recruit even one subject, and that 85% of clinical trials are delayed because of insufficient subject enrollment – so Fox’s initiative (and others like it that … Read More »
A Rose By Any Other Name … May Carry A Higher Duty Rate
As countries work to harmonize international trading rules and develop bilateral and regional Free Trade Agreements (FTA), there remain certain international trade truths that all international traders should understand. Central to those is the principle of tariff classification. No matter the country, all imported products must be classified under the Harmonized Tariff System and will be assessed duty at the corresponding duty rate applied by the importing country. This globally managed system of tariff classification is guided by the World Customs Organization (WCO) and applies to all WCO member states.
International trade truth number two is that all merchandise must be classified, and therefore assessed duty, based on its condition at the time of entry. Tariff classification may be based on a variety of factors, including what a product is, its material composition, how it works, where it is used, and to whom it … Read More »