Evolving brand-name and generic drug competition may warrant a revision of the Hatch-Waxman Act.

The evolution of pharmaceutical competition since Congress passed the Hatch-Waxman Act in 1984 raises questions about whether the act's intended balance of incentives for cost savings and continued innovation has been achieved. Generic drug usage and challenges to brand-name drugs' patents have increased markedly, resulting in greatly increased cost savings but also potentially reduced incentives for innovators. Congress should review whether Hatch-Waxman is achieving its intended purpose of balancing incentives for generics and innovation. It also should consider whether the law should be amended so that some of its provisions are brought more in line with recently enacted legislation governing approval of so-called biosimilars, or the corollary for biologics of generic competition for small-molecule drugs.

Percutaneous Revision of a Testicular Prosthesis is Safe, Cost-effective, and Provides Good Patient Satisfaction.

Office-based percutaneous revision of a testicular prosthesis has never been reported. A patient received a testicular prosthesis but was dissatisfied with the firmness of the implant. In an office setting, the prosthesis was inflated with additional fluid via a percutaneous approach. Evaluated outcomes included patient satisfaction, prosthesis size, recovery time, and cost savings. The patient was satisfied, with no infection, leak, or complication after more than 1 year of follow-up, at significantly less cost than revision surgery. Percutaneous adjustment of testicular prosthesis fill-volume can be safe, inexpensive, and result in good patient satisfaction.