Regulation of neuropharmaceuticals and neurodevices fall under two different centers within the FDA. Pharmaceuticals are overseen by the Center for Drug Evaluation and Research (CDER), while devices are overseen by the Center for Devices and Radiological Health (CDRH).

The Current FDA Neuropharmaceutical Approval Process

Manufacturers who intend to market a new drug must go through a very complex and expensive process. Bringing a new drug to market can take a drug maker 10-15 years at a cost of over $800 million. There are several steps involved in obtaining FDA approval for a new drug (which is getting more difficult)

The first step is to submit an Investigational New Drug (IND) application to the FDA that contains preclinical information: animal pharmacology and toxicology data to determine if the product is safe for initial testing in humans; information on the chemistry, manufacturing & controls to determine if company can produce drug consistently; and the clinical protocols to determine if the methods for conducting the study will cause harm to human test subjects.

When the FDA has cleared the IND application, the drug manufacturer can conduct clinical trials for the drug on patients living within the United States. Clinical trials have three phases:

Phase I: Study of drug in 20 to 80 healthy human volunteers for up to one year to provide information on the drug's toxicity and potential side effects.

Phase II: This type of study is conducted on patients with the targeted disease that the drug is intended to treat over two years to test the drug's safety and efficacy.

Phase III: This is the most comprehensive of the investigational studies focusing on a large number of patients (typically several hundred to several thousand) for approximately two to four years, depending on the drug and the patient population.

Once the manufacturer has successfully completed three phases of clinical studies on an investigational drug, they submit the information as part of a New Drug Application (NDA). Along with the clinical trial results, the manufacturer must also provide: the technical instructions for using the product and the promotional materials used to market the drug to consumers to ensure the claims are appropriate; a manufacturing summary that details of how the drug will be prepared and manufactured and what controls are in place to guarantee a consistent product; non-clinical Information on how the drug should be administered, to whom and at what doses; and a risk/benefit analysis.

The drug maker's submission is reviewed by the FDA and if the drug is granted NDA approval, the FDA may require that the drug maker engage in a phase IV clinical study, which may be larger and longer term than the phase III trial. The phase IV study is designed to monitor the ongoing safety and efficacy of the drug.

Are we ready for FasterCures yet? Check out this suggested process for accelerating the approval process. Indeed, recent events have begun to make many question the concept of accelerating the process at all. Watch out for Pharma's horizontal future.