A group of lawmakers on both sides of the aisle are requesting information about the Food and Drug Administration’s approval process, which sometimes includes making drug companies perform costly experiments on dogs.
More than a dozen members of Congress, including Republican Rep. Scott Perry and Democratic Rep. Brendan Boyle of Pennsylvania, sent a letter to FDA Commissioner Stephen Hahn on Wednesday demanding answers on the practice, which is not required by law.
“We are writing to request information about FDA policies mandating that drug companies conduct testing on dogs to fulfill regulatory requirements,” they wrote in the letter obtained by the Washington Examiner. “Several companies, including those developing vaccines and treatments for COVID-19, have questioned the need for these animal tests typically mandated by the FDA.”
“We are concerned by reports that the FDA has sometimes not allowed companies to use alternatives to animal testing that are more accurate, cost-effective and efficient,” they added. “We want to ensure that unnecessary FDA animal testing red tape does not pose obstacles to medical innovation or slow development of safe and effective drugs, including COVID-19 vaccines and therapies that are desperately needed to restore public health and fully re-open the economy.”
The lawmakers proceeded to request information on “all relevant laws, regulations and guidances that FDA relies on to require or recommend dog testing by drug makers.”
For decades, the FDA has forced some pharmaceutical companies to pay to test their products on dogs even though organizations have voiced opposition, according to taxpayer watchdog White Coat Waste Project. Such experiments have reportedly involved “pumping experimental drugs into puppies’ throats or forcing them to inhale compounds every day for months, often providing no pain relief, and then killing and dissecting the dogs.”
Despite the FDA allowing companies to pursue “an alternative approach if the approach satisfies the requirements of the applicable statutes and regulations,” the Government Accountability Office and others have documented the agency’s refusal in some instances to allow companies to use alternatives to fulfill regulatory requirements.
“For too long, the FDA has forced drug companies to torture and kill puppies in wasteful and unnecessary tests before allowing safe, effective drugs to come to market. These slow and misleading tests harm drug makers, patients, and puppies, all of whom need regulatory relief now — a call with particular urgency during the COVID-19 pandemic,” Justin Goodman, vice president of advocacy and public policy at WCWP, told the Washington Examiner.
In addition to Wednesday’s letter, lawmakers are also taking aim at the FDA’s approval process through spending legislation. Earlier this month, the full House Appropriations Committee unanimously passed its 2021 FDA funding bill, which includes a measure directing the agency to issue a report on how drugmakers can avoid dog testing mandates in favor of alternative methods and to revise its regulations.
“Science has come a long way and there are now better ways to assess the safety of drugs than conducting deadly experiments on dogs. The current FDA regulations fail to account for newer, modern approaches to drug development that do not involve dog testing,” Boyle said in a statement. “FDA must update these outdated testing requirements and explain how they can be avoided in favor of more humane, economical, and effective testing alternatives. There is no reason we need to require animal testing if they rarely predict human outcomes.”
The FDA did not immediately respond to the Washington Examiner‘s request for comment.
