Generic Pharmaceuticals as a Source of Diuretic Contamination in Athletes Subject to Sport Drug Testing

This paper describes nine instances of positive anti-doping tests that could be accounted for by the use of permitted generic prescription drugs contaminated with diuretics, which are prohibited in sport at all times under the WADA Prohibited List. The contamination levels found in the medications are reported and were below FDA limits for manufacturers that are based primarily on safety considerations. These cases demonstrate that great care must be taken to identify the source of low-level anti-doping positives for diuretics reported by WADA-accredited laboratories, and possibly other prohibited substances as well, in order to avoid sanctioning innocent athletes. An evaluation of the cases in this paper supports an approach which establishes a laboratory minimum reporting level (MRL) for diuretics found most commonly in medications. A global consensus after extensive review of similar anti-doping cases has resulted in implementation of a recently announced solution regarding potential diuretic contamination cases.

Co-crystals for Generic Pharmaceuticals: An Outlook on Solid Oral Dosage Formulations.

Co-crystal is an attractive alternative new class of solid forms because that can be engineered to have desired physicochemical properties. Co-crystals have gained considerable attention from the generic pharmaceutical industry after the USFDA released its finalized guidance in the year 2018 on the regulatory classification of co-crystals. In this review, we discussed how co-crystals can be explored as a potential alternative solid form for the development of a generic product that meets the legal, regulatory, and bioequivalence requirements. In the contents, we discussed in detail concepts such as the selection of coformers, various ways of making co-crystals, the strategy of characterization to discriminate between co-crystal and salt, polymorphism in co-crystals, the aspects of intellectual property and, finally, the regulatory aspects of co-crystals.

The Price to Consumers of Generic Pharmaceuticals: Beyond the Headlines

Generic drug prices have received a great deal of attention in the past few years. Many agencies have conducted investigations into the pricing patterns for generic drugs. Price spikes for several specific generic drugs have also been widely reported in the media. Today, 90% of all retail prescriptions sold in the United States are generic drugs. Thus, these prices affect affordability of prescription drugs. We construct two Laspeyres chained price indexes for generic prescription drugs. The first reflects direct out-of-pocket payments by consumers to pharmacies for dispensing generic prescription drugs. The second measures the total price received by the pharmacy (the direct out-of-pocket payment plus the price paid to the pharmacy by the insurer). The chained direct out-of-pocket consumer price index we construct shows a roughly 50% decline for generic prescription drugs between 2007 and 2016. The total consumer price index for generic prescription drugs fell by nearly 80%.

Premium-Priced, Branded Generic Pharmaceuticals in Emerging Economies

Is it socially responsible to price at a premium, company branded generic pharmaceuticals in emerging economies? Building toward an answer to this question, the study first describes the role of the branded generic sector in the economic success of the global pharmaceutical industry. Second, the concept of “shared value,” i.e., the link between competitive advantage (and its theoretical antecedents found in corporate reputation and signaling theory) and corporate social responsibility (CSR), is introduced and applied to the global pharmaceutical industry’s position on marketing generic pharmaceuticals. Third, an empirical evaluation ascertains whether there is sufficient shared value for this company branded generics pricing strategy to be considered “socially responsible.” Fourth, after concluding there is sufficient shared value, a discussion section offers a public/private (corporate and industry self-regulation) framework that will help ensure that safe and effective pharmaceuticals are sold to consumers in developing economies. Lastly, a summary and conclusion section completes the article.