The FDA removed some paperwork physicians are required to complete to obtain experimental drugs for certain patients with immediately life-threatening illnesses, according to Kaiser Health Mews.
Here are five notes:
1. The updated requirements will mandate physicians file an application consisting of 11 questions, four less than the older form.
2. The FDA said the truncated application should allow physicians to complete the paperwork in 45 minutes.
3. The agency designed the new form with individualized patients in mind, as the older format was not specified for the individual. Rather, the physician would fill out the form on behalf of a small or large group of patients.
4. The form is in accordance with the FDA's larger initiatives to make experimental drugs more readily attainable for specific patients. Throughout the United States, 20 states have "right to try" laws which aid terminally ill patients in obtaining access to experimental treatments.
5. However, the updated form does not remove all time obstacles; doctors must obtain a letter of authorization from that drug's manufacturer. Manufacturers might choose to deny requests if they have concerns pertaining to a drug's liability. Following the manufacturer's consent, physicians then submit the application to the FDA, which has an approval rate of 99 percent for such applications.
