- FDA is stepping up enforcement. This shouldn't come as a surprise if you've been following the agency's enforcement actions lately. In his speech to the food and dietary supplement industry, FDA's Chief Counsel Ralph S. Tyler stated that the agency has just began its enforcement efforts and that more are yet to come. Among the areas of concern are the good manufacturing practices (GMP) regulations for dietary supplement products, as well as the notification requirements for new dietary ingredients. The agency also intends to hold individual more accountable for violations, which would result in more criminal prosecutions of company executives and even employees.
- FTC is stepping up enforcement. Similarly, the FTC is stepping up enforcement in the area of claim substantiation. The FTC will be looking at scientific data more closely to determine whether they support claims made about a product. Companies should pay more attention to testimonials, because according to the government, they are never substantiated.
- Companies are very interested in the Chinese market, but are frustrated by the regulatory framework there. Among the conference speakers were five officials from the Chinese State FDA (SFDA), who provided an overview of the medical device approval process in China. This presentation was one of the popular ones at the conference, and the numbers and types of the questions asked at the end of the presentation showed many companies (large and small) are very interested in the Chinese market, and yet are frustrated with the lack of transparency in the approval process. Here are some of the policies that can cause frustration:
- According to a SFDA official, if a foreign company manufactures a medical device in China, the company will have to export the finished product out of China. However, if a Chinese company puts its own label on the same product, it will be able to sell the device in China. This policy seems to have little to do with safety and efficacy.
- Also according to the same official, a medical device imported into China will not receive SFDA approval if the device has not received market approval in the country of origin. The message seemed to be: if this device is not good for your country, it's not good enough for China.
- Questions were asked about whether the SFDA would accept data from clinical trials done outside of the China. The answer was as clear as water - generally no, but we will decide on a case by case basis, but if we decided you need to do more clinical trials, you need to conduct them in China.
- Questions were asked about whether the SFDA would meet with companies to discuss their products before the companies submit their applications for approval of their products. The answer was that the SFDA holds a "open forum" every Thursday during which anyone can participate in a Q&A session with the agency to discuss any regulatory issues. According to the SFDA official, no appointment is required and people can participate by phone. So much for confidentiality.
I am still reviewing my notes and materials from the conference, and plan to blog about other interesting topics I ran across there.
