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.

An Automated Surveillance Strategy to Identify Infectious Complications After Cardiac Implantable Electronic Device Procedures.

Background.  The optimum approach for infectious complication surveillance for cardiac implantable electronic device (CIED) procedures is unclear. We created an automated surveillance tool for infectious complications after CIED procedures. Methods.  Adults having CIED procedures between January 1, 2005 and December 31, 2011 at Duke University Hospital were identified retrospectively using International Classification of Diseases, 9th revision (ICD-9) procedure codes. Potential infections were identified with combinations of ICD-9 diagnosis codes and microbiology data for 365 days postprocedure. All microbiology-identified and a subset of ICD-9 code-identified possible cases, as well as a subset of procedures without microbiology or ICD-9 codes, were reviewed. Test performance characteristics for specific queries were calculated. Results.  Overall, 6097 patients had 7137 procedures. Of these, 1686 procedures with potential infectious complications were identified: 174 by both ICD-9 code and microbiology, 14 only by microbiology, and 1498 only by ICD-9 criteria. We reviewed 558 potential cases, including all 188 microbiology-identified cases, 250 randomly selected ICD-9 cases, and 120 with neither. Overall, 65 unique infections were identified, including 5 of 250 reviewed cases identified only by ICD-9 codes. Queries that included microbiology data and ICD-9 code 996.61 had good overall test performance, with sensitivities of approximately 90% and specificities of approximately 80%. Queries with ICD-9 codes alone had poor specificity. Extrapolation of reviewed infectious rates to nonreviewed cases yields an estimated rate of infection of 1.3%. Conclusions.  Electronic queries with combinations of ICD-9 codes and microbiologic data can be created and have good test performance characteristics for identifying likely infectious complications of CIED procedures.