Allergan’s lawsuit filed against the FDA presents a relatively novel case in addressing the requirements of drug developers in relation to off-label use of drugs by physicians.

Allergan may be one of the many companies to follow suit in time. Allergan’s concern is the FDA’s stance – prohibiting communication to the medical community in regards to the common off-label uses of Allergan’s lead product – poses a violation of the first amendment rights under the US constitution. A pharmaceutical company should be able to exercise its rights under freedom of speech to provide truthful and relevant information to its users: physicians.

More questions than answers could be raised following this case. While US regulations governing off-label use and promotion by drug developers may allegedly violate rights, the FDA policy exists for good reason. The drug regulators have laid down an effective set of principles by which the medical and patient communities are protected and are assured safe, effective and objective treatment. However, having acknowledged off-label use of pharmaceutical drugs by the medical community leaves room for further rules and obligations. Politicians in Washington openly discuss the discord inherent in off-label regulation in regards to communications and marketing, representing the elephant in the room of drug development.

The central tenets of pharmaceutical regulation have always been safety and efficacy. A drug must provide proof that it delivers on both to receive approval for on-label use. The premise for on-label implicitly excluded the concept for off-label, meaning that safety and efficacy data were not specific to these conditions discovered by physicians post-approval. Therefore, one may argue that these conditions were not part of satisfactory evidence required to receive FDA approval in the first place. What the FDA attempts to enforce nowadays – and as part of regulators’ modern viewpoint – is to insist that drug developers communicate evidence on safety for off-label use (including the risks and negative information) without the opportunity by drug developers to reveal the efficacy, or benefits. I do not believe this case should have reached the magistrates in the first place, and fail to see how it will benefit our industry as a whole.

Far from polarising the pharmaceutical industry, this case should serve as an academic case study to analyse where changes are required to be made to assist both the FDA and drug developers in achieving their common objectives. I view that food and drug agencies are urgently asked to play a novel role in regulating global medicinal use, a domestic view no longer holds.

Next week, I will further these thoughts as I believe that regulators require reform in times where pharmaceutical development is under intense scrutiny to produce faster and cheaper dugs. In contrast, the online marketplace has enabled unbridled exchange of chemicals without any regulations to oversee origin, development and use. Here regulators are called to the table faster than any of us had anticipated.

- Philippe Wolgen

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Related Posts:

• Talking off the label – part one
• Talking off the label – part two
• GMP – Good Manufacturing Practice makes perfect

This entry was posted on Friday, November 6th, 2009 at 12:01 pm and is filed under CEO blog. You can follow any responses to this entry through the RSS 2.0 feed. You can leave a response, or trackback from your own site.