FDA Compliance: Minimising Risk

Compliance with Food and Drugs Administration (FDA) guidelines is essential for all working within the pharmaceutical industry, from researchers working on clinical trials to those marketing the drugs to members of the public.

The FDA is tasked with ensuring that all products for human consumption, and healthcare products, including medical devices, pose minimal threat to public safety, and those that fall foul of its guidelines can be dealt heavy penalties.

Regulation of over-the-counter drugs and prescription drugs is conducted by the Center for Drug Evaluation and Research, through the Office of Compliance, which uses policy, observation and enforcement to minimise "unnecessary risk from drugs throughout their lifecycle".

Work undertaken by the office includes developing and overseeing drug compliance programmes and ensuring uniform interpretation of standards.

However, guidelines presented by the FDA are continually evolving to reflect new technologies and challenges presented to the pharmaceutical industry. Companies must ensure that they remain compliant, while still innovating and moving healthcare forwards.

Failing to comply

The FDA brings a number of cases each year against pharmaceutical companies which have failed to comply with its regulations.

One recent example was a case involving SB Pharmco Puerto Rico, Inc, a subsidiary of GlaxoSmithKline, which was found to be failing to adequately ensure the safety and efficacy of its products at one of its manufacturing facilities. 

SB Pharmco Puerto Rico pleaded guilty in relation to the violations at its plant in Cidra, Puerto Rico, which has now closed. The case related to Kytril, Bactroban, Paxil CR, and Avandamet manufactured at the plant between 2001 and 2005.

The FDA said that the firm had failed to ensure Kytril and Bactroban were free of micro organisms and that its processes meant the two layer Paxil CR tablets split, potentially meaning some had no "therapeutic effect" and others had no "controlled release mechanism". Avandame was also said to contain the incorrect mix of active ingredients.

Under the agreement a criminal fine of $150 million (£93 million) was paid, in additional to a $600 million charge in conjunction with a civil settlement.

Mark Dragonetti, special agent in charge, New York Field Office, said: "FDA’s manufacturing standards are designed to ensure the safety and quality of drugs distributed to American consumers. FDA expects pharmaceutical companies to abide by these manufacturing standards and correct deficiencies in an expedited manner."

Marketing compliance

The FDA is also concerned with drugs marketing, to ensure that products are being correctly represented to members of the public.

In May, the organisation launched the Bad Ad Program, designed to help healthcare providers "recognise misleading prescription drug promotion and provide them with an easy way to report this activity to the agency".

Pharmaceutical Research and Manufacturers of America (PhRMA) senior vice president Ken Johnson,  said that the move was a step forward, but that companies already  'devote substantial time and effort, and often ask for input from the Food and Drug Administration (FDA), to ensure that prescription drug communications are accurate and meet all applicable legal requirements'.

Off-label marketing is another key concern for the FDA, one which pharma giant Novartis Pharmaceuticals Corporation (NPC) recently experienced issues with.

The company pleaded guilty to off-label marketing of Trileptal, which is used in the treatment of epilepsy, suggesting it could be utilised for conditions such neuropathic pain and bipolar disease, which it has not received FDA approval for.

NPC paid a $185 million criminal fine and forfeiture, in addition to $237.5 million to solve civil liabilities.

United States attorney Zane David Memeger said: "Pharmaceutical companies have a legal obligation to promote the drugs they manufacture only for uses that the Food and Drug Administration has deemed are safe and effective. That legal obligation takes priority over a company’s bottom line."
[inlinead]