FDA Safety and Innovation Act
The FDA Safety and Innovation Act (FDASIA) (S. 3187) is a large bill that includes parts of much legislation the CCA supports. It passed by large margins in both houses of Congress and is expected to be signed into law by President Obama this summer. Here are some of the highlights:
- PDUFA (Prescription Drug User Fee Act) will be renewed. This provides approximately $6 billion in industry dollars over the next five years to fund the FDA’s drug approval process. This insures that drugs get to market faster and at less cost than would otherwise be the case.
- MDUFA (Medical Device User Fee Act) will be renewed. This provides industry money to speed up the review process. The FDA definition of medical device includes everything from bandages to pet scans. Any new development in colonoscopy screening would fall under MDUFA.
- TREAT (Transforming the Regulatory Environment to Accelerate Access to Treatments Act). The heart of this act was included. This should speed up the clinical trial process by allowing surrogate and clinical endpoints. This also expands PDUFA to cover biologics.
- DRUG SHORTAGE LEGISLATION
FDASIA takes a look at several issues surrounding the drug shortage:
- Narrow Notification requires drug manufacturers to notify FDA of an interruption of the manufacture of a drug that could lead to a disruption in the supply at least six months in advance. This only applies to drugs that are life supporting, life sustaining or treat or prevent a debilitating disease. There are no penalties for failure to comply other than a notification from the secretary of the FDA.
- Root Cause Analysis directs the Government Accountability Office (GAO) to look into the root causes of drug shortages and possible solutions to the problem. The GAO is specifically directed to see if incentives can help alleviate or prevent drug shortages.
- Expedited Reviews/Inspections since some of the blame for drug shortages falls on the FDA’s lengthy review and inspection process, the bill allows for the FDA to expedite the review of a supplement to New Drug Applications (NDAs) that could help mitigate or prevent a shortage. It also allows the FDA to expedite an inspection or re-inspection of an establishment that could help mitigate or prevent a shortage.
There is also language in the bill to require the following:
- FDA notification to relevant stakeholders of impending drug shortages.
- DEA is supposed to look at changing quotas for importing drugs in shortage.
- FDA is supposed to solicit more patient input into the clinical trials process.
How does this impact colon cancer patients?
- Getting new drugs, biologics and medical devices to market faster gets them to patients sooner. They should also be cheaper.
- Generic drugs should also reach the market faster.
- New drugs that appear to have life saving benefits will make it to market quicker.