US FDA is gearing up to vigorously enforce requirements to ensure that clinical research organizations and pharma companies conduct post marketing studies and clinical trials for prescription drugs. The post marketing requirements (PMRs) are approved under section 505 of the Act and biological products approved under section 351 of the Public Health Service Act (the PHS Act) (42 U.S.C. 262).

The regulatory authority has now issued a guidance prepared by the Food and Drug Administration Amendments Act of 2007 (FDAAA) Title IX Working Group. Staff from the Centre for Drug Evaluation and Research (CDER) and the Centre for Biologics Evaluation and Research (CBER) at the Food and Drug Administration have been responsible for the contents of the guidance.

The objective of the guidance is to ensure that safe and effective new drugs are available as quickly as possible. The drugs already marketed remain safe and of the highest quality.

In 2007, Congress passed the Food and Drug Administration Amendments Act of 2007 (FDAAA), which amended the Food, Drug, and Cosmetic Act (the Act). This provided the agency with substantial authority to ensure the safe and appropriate use of drugs. One of these provisions gives FDA the authority to require drug companies to conduct post marketing studies or clinical trials known as post marketing requirements (PMRs). FDA may require these PMRs either at the time of approval or after approval if the agency becomes aware of new safety information that could indicate a serious potential risk associated with the use of the drug, as indicated in Section 505(o)(3) of the Act.

FDA requires the post marketing studies and clinical trials to assess a known serious risk related to the use of the drug. It could also ascertain the signals of a serious risk related to the use of the drug. It will also help to identify an unexpected serious risk when available data indicate the potential for serious risk.

Once FDA notifies a drug sponsor for a post marketing study or clinical trial, the company is required to provide a timetable for completion, including study milestones, and periodic status reports on progress toward completion of the PMRs. If a company fails to comply with the timetable, FDA is authorized to take enforcement action against the company, unless the company can demonstrate good cause for the failures.

The regulatory authority’s enforcement actions may include issuing a warning letter and assessing civil monetary penalties. A company which violates post marketing study requirements may be subject to civil monetary penalties of up to $250,000 per violation, with the possibility of additional monetary penalties if the violation continues uncorrected. In addition, if a company violates post marketing study requirements, its product may be deemed mis-branded, stated the guidance.

Further, the guidance has highlighted that FDA intends to take enforcement action against companies that fail to conduct these required studies in a timely manner.