How Does the FDA Work With the Pharmaceutical Industry?

The FDA researches and approves new drugs for sale in the U.S.

The federal Food and Drug Administration (FDA) has regulated the manufacture and sale of pharmaceuticals in the United States since 1930. Companies that wish to introduce a new drug for sale in the marketplace must petition the FDA. The government agency then evaluates the product for its intended uses and actual effects.

Investigational New Drug

A substance that shows promise must be approved for further testing.

Once a company first determines that a new compound may have a beneficial use through animal trials, it must make an Investigational New Drug (IND) application to the FDA. The IND, if approved after a 30-day review, grants the company the license to perform human testing as well as an exemption from the federal ban against transporting drugs across state lines.

Drug Approval

The FDA only permits drugs demonstrated to be safe and effective.

The pharmaceutical company submits a New Drug Application (NDA) if it discovers that the compound accomplishes a medical goal and is safe for the public to use. The NDA lists all of the available information about the drug and includes the information from the IND. A staff of FDA scientists examines the research of the submitting agency. The drug is a finished product at this point and, pending FDA approval, can be sold in the U.S.

Generics

Generic formulas can differ slightly if they safely produce the same benefits.

Patents filed with the Patent Office protect the product that a pharmaceutical company labors to bring to market. Other manufacturers can apply to produce generic versions once the patent expires. Because the research has already been done, these companies need only fill out an Abbreviated New Drug Application (ANDA) that proves that they know how to consistently manufacture the drug and that any alterations in the formula do not harm the public.

OTC Medications

OTC monographs outline the ingredients and desired effects of nonprescription medications.

Over-the-counter (OTC) medications have less potency, pose less risk to consumer health, and require less paperwork with the FDA for approval. A drug composed of previously approved ingredients -- for example, a new OTC cold elixir -- can be sold without exhaustive documentation of research. The marketing company submits a "monograph", which describes with relative brevity the essential information about the product.

Adverse Events

Patients or caregivers must report side effects for the FDA to take action.

Sometimes a negative effect of a drug is not immediately apparent. The FDA monitors continuing safety concerns through the Adverse Event Reporting System (AERS). The AERS relies on voluntary evidence provided by doctors and consumers, although drug companies who receive complaints are required to convey this information to the FDA. Products shown to pose risks prompt action that can include additional studies, changes in labeling or drug revocation.

References

• Food and Drug Administration: Drugs