FDA adds last minute clause into package of patient reforms that protects pharmaceutical industry from litigation in cases of side effects

Simon Collins, HIV i-Base

An article in the 8 June edition of New England Journal of Medicine has drawn attention to important recent changes in the US regulatory requirements.

From 30 June the FDA requires new rules on information that have been publicised as measures to increase patient safety. These include label changes to reorganise information including highlighting most commons safety concerns and adding a table of contents.

The urgency of these small changes are perhaps highlighted by the timetable for changes. Drugs already licensed will have 3-7 years to implement similar label changes, and drugs approved prior to 2001 are excluded altogether.

All these changes were open to an extended period of consultation, but after this closed, a new section was added that protects companies from legislation for purposes of litigation. The wording is such that it virtually preempts any litigation by patients who are injured from using a drug, even if the company failed to adequately warn patients of a known risk, unless they can prove that the company intentionally committed fraud.

The article also negatively compares the professional reference manual for drug listings in the US (the pharma-sponsored Physician’s Desk Manual) with the British National Formulary (, for grouping drugs by manufacturer rather than by class (preventing easy comparisons within a drug class) and for financial links with industry.

Additionally, for an organisation that is apparently interested in increasing patient safety and risk awareness, the article highlights how difficult the FDA website is to when trying to access information.


The US pharmaceutical lobby have been trying to reduce options for legal liability for several years. It is difficult to see how challenges to this legislation could be effective in the current US political climate.


Avorn J, Shrank W. Highlights and a hidden hazard – the FDA’s new labelling regulations. NEJM 8 June 2006. 354 (23):2409-2411.

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