FDA files complaint against Laclede for illegally distributing OTC drug products
SILVER SPRING, Md. — On June 25, the U.S. Department of Justice, at the request of the Food and Drug Administration, filed a complaint for permanent injunction in the U.S. District Court for the Central District of California against Laclede of Rancho Dominguez, Calif., and its president, Michael Pellico. The complaint claims that Laclede illegally distributes over-the-counter vaginal drug products without required FDA approval.
CDC: Opioid prescribing varies widely by state
ATLANTA — Health care providers wrote 259 million prescriptions for opioid painkillers in 2012 — many more in some states than in others — according to a Vital Signs report released Tuesday by the Centers for Disease Control and Prevention that highlights the danger of overdose. The report also includes an example of a state that reversed its overdose trend.
- Southern states — Alabama, Tennessee, and West Virginia in particular — had the most painkiller prescriptions per person;
- The Northeast, especially Maine and New Hampshire, had the most prescriptions per person for long-acting/extended-release painkillers and for high-dose painkillers; and
- State variation was the greatest for oxymorphone (a specific type of painkiller), among all prescription painkillers. Nearly 22 times as many prescriptions were written for oxymorphone in Tennessee as were written in Minnesota.
- Considering ways to increase use of prescription drug monitoring programs, which are state-run databases that track prescriptions for painkillers and can help find problems in overprescribing. Impact of these programs is greater when they make data available in real time, are universal (used by all prescribers for all prescriptions for all controlled substances), and are actively managed (for example, send alerts to prescribers when problems are identified);
- Considering policy options, including laws and regulation, relating to pain clinics to reduce prescribing practices that are risky to patients;
- Evaluating their own data and programs and considering ways to assess their Medicaid, workers’ compensation programs, and other state-run health plans to detect and address inappropriate prescribing of painkillers; and
- Identifying opportunities to increase access to substance abuse treatment and considering expanding first responder access to naloxone, a drug used when people overdose.