FDA issues draft guidance to investigators, manufacturers of artificial pancreas systems
SILVER SPRING, Md. — In an effort to help advance the development of devices that automatically monitor blood glucose and provide proper insulin doses in people with Type 1 diabetes, the Food and Drug Administration has issued draft guidance to help investigators and manufacturers as they develop and seek approval for these products.
The FDA said the development for artificial pancreas device systems potentially could reduce the risk of dangerous complications caused by Type 1 diabetes, such as extreme blood-glucose levels, among others. The agency’s draft guidance includes such recommendations as a three-phase clinical study progression in order for studies to move to an outpatient setting as quickly as possible, the FDA said.
“The FDA is focused on improving the process for the study and approval of artificial pancreas systems, and developed this guidance to provide maximum flexibility to manufacturers seeking to bring this device to U.S. patients,” said Jeffrey Shuren, director of the FDA’s Center for Devices and Radiological Health. “We understand how this device could change the lives of millions of Americans with diabetes, and we want our safety and effectiveness review to give patients the confidence that the device works.”
Type 1 diabetes is a condition that occurs when the immune system attacks insulin-producing pancreatic beta cells, thus forcing patients to rely on injections, pumps or other devices to maintain their blood-glucose levels.
For the full draft guidance, click here.
Senators look into Pfizer-PBM deal for Lipitor
NEW YORK — Pfizer’s efforts to protect the sales of its blockbuster cholesterol drug Lipitor have attracted scrutiny from members of Congress, according to published reports.
The New York Times reported Thursday that three senators — Max Baucus, D-Mont.; Chuck Grassley, R-Iowa; and Herb Kohl, D-Wis. — had asked Pfizer and five other companies to provide details of their agreements to prevent dispensing of generic versions of Lipitor (atorvastatin) and dispense only the branded version.
Ranbaxy Labs announced the launch of its generic version of Lipitor Wednesday night, following Watson Pharmaceuticals’ launch of an authorized generic version of the drug, following the expiration of Lipitor’s patent protection. Lipitor is the world’s highest-selling drug, with sales of $7.8 billion in the United States during the 12-month period ended in September, according to IMS Health.
The Times reported last month that Pfizer had made a deal with pharmacy benefit managers timed to coincide with Ranbaxy’s exclusivity period, whereby the PBMs would instruct pharmacies to fill prescriptions with branded Lipitor and then charge customers the same co-pay that they would for the generic version. The Times quoted critics of the deal as saying that while patients would be charged the lower co-pay, payers would still have to pay the full price.
Pfizer also made a deal with Diplomat Specialty Pharmacy to sell Lipitor directly to consumers through the mail at a reduced price.
CVS Caremark names Randy Falkenrath SVP specialty pharmacy
WOONSOCKET, R.I. — CVS Caremark has announced the appointment of Randy Falkenrath as SVP specialty pharmacy, with responsibility for the ongoing development of clinical programs and product management to support the company’s specialty pharmacy business.
Falkenrath brings more than 26 years of experience in the health plan, pharmaceutical and medical device industries to his new position at CVS Caremark. Over the past nine months, Falkenrath worked within the company’s specialty field operations group. Prior to joining CVS Caremark, Falkenrath was SVP specialty pharmacy and business development for UnitedHealthcare’s commercial pharmacy benefit management business. Previously, Falkenrath was a partner in the life sciences consulting division of Computer Sciences Corporation and also held leadership positions at Baxter International and Searle Pharmaceuticals.
"Specialty pharmacy is an important growth area for CVS Caremark over the next few years, and Randy Falkenrath’s in-depth experience and knowledge of the industry make him uniquely qualified to lead our specialty pharmacy business," stated Jon Roberts, EVP and COO for the CVS Caremark PBM business. "His expertise will enable us to continue to enhance our specialty pharmacy leadership and identify further opportunities for integration across the CVS Caremark enterprise so we can better help patients dealing with complex, debilitating diseases on their path to better health."