The US Food and Drug Administration seems mildly discomfited. It’s not a state that one usually associates with the most powerful regulator of the pharmaceutical and medtech sectors globally. That fact a small, one-drug Irish company is responsible for this state of affairs only adds to the intrigue.
The company, Amarin, has taken a pre-emptive First Amendment case, accusing the FDA of restricting its right to free speech.
At issue is its drug Vascepa, a purified Omega-3 fish oil that helps lower very high levels of triglycerides – blood fats that can cause cardiovascular disease – in patients without the side effects present in the current blockbuster market leading therapy.
Amarin has FDA approval to market the drug to patients with very high triglyceride levels but not to those with less extreme readings. For Amarin, the difference is a potential market of 35 million patients against its current four-million strong market.
The company says it wants to share with doctors the positive results of a 2011 study on the impact for the larger patient group and other information about “supportive but not conclusive” research that its drug could reduce coronary disease.
In an initial response to the lawsuit, the FDA appeared to try to undermine Amarin’s action, saying it had no real objection to Amarin sharing the data in question with healthcare providers.
"FDA does not have concerns with much of the information you proposed to communicate," said the letter to Amarin signed by Janet Woodcock director of the agency's Center for Drug Evaluation and Research, and filed with the court. Since then, the FDA has filed a responding brief in court to Amarin's action. It accuses the Irish minnow of launching a "frontal assault" on the framework for drug approval. Success for Amarin "has the potential to establish precedent that would return the country to the pre-1962 era when companies were not required to prove that their drugs were safe and effective for each of their intended uses", it warns.
Strong stuff indeed. The FDA has the deep pockets for a protracted court battle, one of the reasons actions such as Amarin’s are so rare. Lose, and Amarin runs the risk of ruin: win and it still faces having to work with a possibly belligerent regulator.
The Irish company has obviously decided that, in the fast-moving world of drug development, avoiding confrontation and waiting several years for yet more (hopefully) supportive data is a path it cannot afford to take. It needs to win.
