NACDS proposes ‘one-document solution’ for medication info to the FDA
ALEXANDRIA, Va. — The Obama administration recently called on the public for ideas to streamline federal regulations. In response, the National Association of Chain Drug Stores has sent its suggestion to the Food and Drug Administration.
In a letter submitted to FDA commissioner Margaret Hamburg on Monday, NACDS told the agency that it should focus on streamlining patient medication information, or PMI. Currently, the FDA requires pharmacies to provide patients with several different types of information on prescription medications, including medication guides, patient package inserts and consumer medication information, NACDS said. Often, the information is penned by several authors and therefore may be too complex for patients to comprehend.
To mitigate this, NACDS suggested that the FDA implement a "one-document solution," which would "provide patients with useful and focused information on their prescription medications and allow pharmacies to advise and counsel patients on adhering to prescription medication," the organization wrote.
"We urge the FDA to elevate the transition from medication guides, patient package inserts and other consumer medication information to the ‘one-document solution’ PMI to be among the FDA’s highest priorities,” NACDS said.
NACDS first proposed a "one-document solution" for PMI in 2007.
Study: Tradjenta reduces blood sugar, weight among patients
SAN DIEGO — New data from a late-stage clinical trial of a recently approved drug for Type 2 diabetes show improved blood-sugar control in adults who take it with metformin or alone.
Boehringer Ingelheim and Eli Lilly presented data from the study of Tradjenta (linagliptin) at the American Diabetes Association’s 71st Scientific Sessions in San Diego last weekend. The study showed reductions in blood sugar and weight, and a low incidence of abnormally low blood sugar, known as hypoglycemia.
The FDA approved Tradjenta as a treatment for Type 2 diabetes in May.
Gilead, Tibotec to develop HIV drug
CORK, Ireland — A subsidiary of Johnson & Johnson and Gilead Sciences will collaborate to develop a combination drug for HIV, the two companies said Tuesday.
Gilead and Tibotec Pharmaceuticals will work to create a once-daily, single-tablet combination of Tibotec’s Prezista (darunavir) and Gilead’s investigational drug cobicistat, a so-called boosting agent.
“We are excited to be able to study and develop Prezista with an alternative boosting agent in a combination product that has the potential to reduce the number of tablets patients take,” said Johan Van Hoof, global therapeutic area head for infectious diseases and vaccines for Janssen Pharmaceutica, another subsidiary of J&J that is Tibotec’s parent.