A new lawsuit from a pharmaceutical company that sells a drug that prevents ovarian cancer from spreading has drawn attention from the White House.
The RCA filed a lawsuit Thursday against the National Institutes of Health and the pharmaceutical company BioMed Central Inc. in a U.S. District Court in Maryland that seeks class-action status.
The drug, called Regeneron, is one of the top-selling medications in the United States, and it’s the only one of several treatments approved by the Food and Drug Administration to prevent ovarian cancer.
RCA said the lawsuit was filed to challenge the government’s approval of the drug and its potential for “dramatic, irreversible harm to millions of women and men worldwide.”
“This is the first time in history that a single drug has been approved by both the FDA and the CDC, and its effects have already been demonstrated in women and children in the U.K. and in the Netherlands,” RCA said in a statement.
“The RIAA’s lawsuit seeks to hold the FDA responsible for its decision to approve this drug without the necessary studies and clinical trials.”
The FDA’s approval is the subject of a separate class-wide lawsuit by the American Cancer Society.
The American Cancer Societies lawsuit is asking the court to declare that the FDA’s decision to deny approval to Regeneron violated federal law and the American Health Care Act, a law that requires the agency to conduct all reviews of new drugs and medical devices.
“The decision to allow this drug to be approved despite the substantial evidence that it would cause cancer to grow and spread in women is beyond the pale,” said the American Association of Cancer Research, which represents thousands of cancer experts.
BioMed Central declined to comment for this story.
A spokesman for the RIAAs office of public affairs declined to discuss the lawsuit.
The lawsuit says Regeneron has been “an effective and well-tolerated treatment for ovarian cancer since 2003,” when it was approved by regulators in the UK.
It said it has been used by more than 20,000 patients.
It is now the most widely prescribed ovarian cancer drug in the world, with sales of the RTA drug at $1.5 billion.
In its lawsuit, RCA says it was unable to get approval to sell Regeneron to other countries because of concerns over the potential harm to the health of women.
It cites studies in Britain and France that show Regeneron is not effective in preventing ovarian cancer in women who have already developed ovarian cancer or have already died.
It also points out that the company has a long history of raising prices and cutting down on its product development.
It also says it’s not aware of any studies showing that Regeneron prevents ovarian cancers from spreading.RCA’s lawsuit cites a study in the British Medical Journal that found the drug could not be used to prevent or slow ovarian cancer spreading.
The company said that study was flawed, because it didn’t consider the side effects of using the drug in women with other types of ovarian cancer, which include breast cancer, lung cancer, prostate cancer and ovarian cancer that’s spread to other parts of the body.
The FDA did not immediately respond to a request for comment.