Search

The article discusses the controversy over the legality of the so-called pay for delay settlements to resolve disputes over drug patents in the U.S. The Federal Trade Commission (FTC) has called for making some pay-for-delay settlements presumptively illegal. The role played by the Hatch-Waxman Act of 1984 and the so-called Paragraph IV challenges in the emergence of the controversy is explained. Other topics discussed are concerned with antitrust law and the availability of generic drugs.

The article presents an overview of the protein based therapeutics market, which began with the approval of recombinant human insulin (Humulin) by the U.S. Food and Drug Administration. A discussion off the advantages and disadvantages of protein based therapeutics and generic alternatives to them, and on U.S. Congressional plans to regulate and control protein based therapeutics, is presented. Research which has been conducted on protein based therapeutics and laws passed by the U.S. Congress concerning their use are discussed.

The article discusses the U.S. Supreme Court case Pliva v. Mensing, which concerns the failure of metoclopramide manufacturer Pliva to warn physicians and patients about the risk of tardive dyskinesia associated with its long-term use. The Supreme Court ruled that brand-name drug manufacturers had a duty to update their labels, however, Pliva is not liable in state court for not updating their labels to integrate new warning information since it is a generic drug manufacturer.

The article discusses the U.S. Food and Drug Administration (FDA) Safety and Innovation Act (FDASIA). The Act extends user fees to generic drugs manufacturers in order to offer greater funding for FDA's generic-drug reviewers. It ensures that FDA will receive the user-fee funding that it needs to help promote review efficiency. However, the author argues that the ACT failed to promote more robust postmarketing systems to validate the effectiveness and safety of marketed products.

The article reports that legislation permitting the U.S. government to negotiate Medicare drug prices has been weakened after pushback from the pharmaceutical industry. Topics include government's costs for filling prescriptions in federal programs; and medications by means of the National Institutes of Health (NIH) to fund biomedical research.

A response from authors of the article "High-Cost Generic Drugs - Implications for Patients and Policymakers" in the November 13, 2014 issue is presented.

The article focuses on the implications of high-cost generic drugs on patients and policymakers in the U.S. Topics discussed include the need for the Food and Drug Administration (FDA) to create a way to promote competition and allow private market to function effectively, standard processing of generic drug approval, link of generic drug shortage with increase in price, and importance of implementing regulation to reduce price of older generic drugs.

The article reports that the U.S. prices of older generic medications such as albuterol sulfate, enalapril and fluoxetine have increased. Topics discussed include high prescription-drug spending market because of exclusivity and negotiating power, prohibition of prescription drugs importation under the Food, Drug, and Cosmetic Act, and need of alternative strategies to provide less expensive medications.

The article discusses the access to injectable generic drugs, with focus on bacille Calmette-Guérin for bladder cancer. It notes the prospect of a sustained shortage or substantial price increase after a BCG manufacturer announces in November 2016 to exit the market in mid-2017. It illustrates the price increase of mitomycin, thiotepa, and valrubicin during the BCG shortage beginning in 2014. Also noted is payment reforms which could further stabilize the generic injectable agents market.