Pharmaceutical and medical device companies have long grumbled about the U.S. Food and Drug Administration‘s process for getting new products approved. Some say it’s too long. Others say it’s restrictive. Many say it’s just not clear.
FDA Commissioner Dr. Margaret Hamburg heard many of those concerns in person during a visit to North Carolina’s Research Triangle. In addition to meeting with several life sciences companies and business leaders, Hamburg toured the new Novartis (NYSE:NVS) vaccine plant in Holly Springs, North Carolina.
The visit Thursday was part of a larger FDA outreach effort. Hamburg said that she’s been doing a series of meetings with CEOs and entrepreneurs in the drug, device and food industries to get their perspectives on bringing products through the regulatory process and working with the agency.
“We want to be as effective as possible and the best way to really understand is to listen to both the good and the bad,” Hamburg said in an interview.
The FDA’s outreach goes beyond talking to industry. Jeff Shuren, director of the FDA’s Center for Devices and Radiological Health, has participated in six town hall-style meetings in the last two years; the most recent one was last week in San Francisco. Shuren said the meetings are wide-ranging and cover business issues as well as food and drug safety.
Hamburg said one North Carolina company told her its product was ultimately improved by having gone through the FDA’s regulatory process. But the agency also hears its share of criticism. Over the summer, the Institute of Medicine issued a report critical of the FDA’s 510(k) regulatory process for new medical devices. The IOM suggested that the process be abandoned. That’s not going to happen. Hamburg said the FDA was surprised by the IOM report and its recommendations are not binding. But Hamburg did say the agency will work to streamline and modernize the process. Below are some of highlights of Hamburg’s interview with MedCity News.
Hamburg’s response to industry concerns about the regulatory process:
A Deep-dive Into Specialty Pharma
A specialty drug is a class of prescription medications used to treat complex, chronic or rare medical conditions. Although this classification was originally intended to define the treatment of rare, also termed “orphan” diseases, affecting fewer than 200,000 people in the US, more recently, specialty drugs have emerged as the cornerstone of treatment for chronic and complex diseases such as cancer, autoimmune conditions, diabetes, hepatitis C, and HIV/AIDS.
How federal government budget cuts could affect the FDA:
Hamburg’s thoughts on the IOM’s 510(k) assessment and possible changes to the 510(k) process:
