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…current prescription and Over-the-Counter drug (“OTC”) classes – insofar as there would be no expectation that BTC drugs would eventually switch to the prescription or OTC class. The second view is…
…referred to the House Ways and Means and Energy and Commerce Committees where it has remained dormant. Rep. Stark introduced similar versions of the Fair Balance Prescription Drug Advertisement Act…
…PREA’s (and thus FFDCA’s) requirements. FDA’s PLAN B approval has been controversial. It seems unlikely, however, that the AAPS complaint -despite some novel arguments- will result in FDA withdrawing approval….
…most common type of abused prescription drug, and are most commonly involved in overdose incidents. The availability of heroin continued to increase in 2012, likely due to high levels of…
…less than 2,300 mg (and to 1,500 mg for certain at-risk populations), consume less than 300 mg per day of dietary cholesterol, limit foods containing synthetic sources of trans fats,…
…Model for payment of certain drugs covered under Medicare Part B. 83 Fed. Reg. 54546 (Oct. 30, 2018). This is not the first time that CMS has attempted to test…
…the customer can place an order” (emphasis added) includes an establishment’s homepage (e.g., www.CafeEtan.com), or only the specific webpage from which customers can place an order (e.g., www.CafeEtan.com/order). It is also…
…or need more information, contact: Frank J. Sasinowski, fsasinowski@hpm.com, 202-737-4287 Josephine M. Torrente, jtorrente@hpm.com, 202-737-7554 David B. Clissold, dclissold@hpm.com, 202-737-7545 James E. Valentine, jvalentine@hpm.com, 202-724-1745 Michelle L. Butler, mbutler@hpm.com, 202-737-7551…
…or need more information, contact: Frank J. Sasinowski, fsasinowski@hpm.com, 202-737-4287 Josephine M. Torrente, jtorrente@hpm.com, 202-737-7554 David B. Clissold, dclissold@hpm.com, 202-737-7545 James E. Valentine, jvalentine@hpm.com, 202-724-1745 Michelle L. Butler, mbutler@hpm.com, 202-737-7551…
…a lot of money to be made by an individual company; while the acetaminophen market may be large, there are just so many market participants. If every company that brings…
…to mitigate risk, including considering offering naloxone when factors that increase risk for opioid-related harms are present. Providers should review the patient’s history of controlled substance prescriptions using state Prescription…
…for the drug; have a diagnosis consistent with a labeled indication; have health insurance that covers prescription drugs (including private, commercial, or government health insurance programs); and have experienced a…
…Gottlieb and HHS Secretary Azar. A proposed rule released today by CMS would require pharmaceutical companies to disclose wholesale acquisition cost (WAC) in TV advertisements for prescription drugs. The rule…
…commerce wholly outside of Maryland. Compl. at 2, 23-27, AAM v. Frosh, No. 1:17-cv-1860 (D. Md. July 6, 2017). The Commerce Clause empowers Congress to regulate commerce “among the several…
…with an annually updated list of sales representatives who market the manufacturer’s prescription drugs to Nevada-licensed, -certified, or -registered HCPs, pharmacies, medical facilities, or individuals licensed or certified under the…