It is ironic that 50 years after the drug thalidomide was found to have caused serious harm to tens of thousands of babies in Europe and Great Britain, but not the U.S., both the Administration and Congress are backing efforts that could unravel the safety net and erode the power of American agencies to protect public health and safety.
The lesson of thalidomide is that regulations matter, and that, in this case, U.S. regulators were more vigilant than their European counterparts. Thalidomide had been used as an over-the-counter sleep aid in Germany since the late 1950s. Since it was marketed as being safe for all, a doctor in Australia started prescribing it to pregnant women to curb morning sickness.
It was only after thousands of pregnant women had used the drug that the truth about thalidomide’s terrible side effects became apparent. The drug caused horrible malformations. Infants were born without limbs, or with disfigured ones. Many died before they reached their first birthday. An estimated 10,000 children, nearly all outside the U.S., were born with these severe birth defects.
The U.S. was largely spared this tragedy because one Food and Drug Administration medical officer, Dr. Frances Kelsey, worried about the lack of data that demonstrated the drug was safe, and concerned about reports of serious side effects, refused to approve the drug.
As FDA Commissioner Margaret Hamburg wrote in February of this year, “Dr. Kelsey’s reaction to thalidomide exemplifies the FDA’s mission: protecting and promoting the health of the American people, using science for regulatory decision-making.”
And yet, if some in Congress and the Administration have their way, the power of agencies like the FDA, the Consumer Product Safety Commission, and the Environmental Protection Agency to protect American families from harm may be eroded.
“Globalization” of our regulations has been promoted ardently by the U.S. Chamber of Commerce and multinational corporations. This corporate push has found allies in high places. In Congress, members of both the House and Senate are proposing changes at the FDA to encourage more globalization of drug and device safety standards.
And on May 1, President Obama issued an executive order that would eliminate “unnecessary regulatory differences” among nations. Writing in the Wall Street Journal, Cass Sunstein, administrator of the White House Office of Information and Regulatory Affairs, contended that this effort was benign, all about promoting exports, growth and job creation. And he promised that, of course, it wouldn’t “undermine American laws or compromise our national prerogatives.”
But here’s the problem: this new executive order will require agencies to “consider reforms to existing significant regulations” if a “stakeholder” complains that an agency regulation contains “unnecessary differences” in standards between the U.S. and a major trading partner. The “stakeholder” must present “adequate” information to make the case, but the obligation on the agency is clear.
How do you define an “unnecessary difference?” How much information does a “stakeholder” have to provide to make the case that the agency should “reform” its regulation to conform to a foreign standard? Which stakeholders are we talking about? The executive order does not answer these questions. When Sunstein addressed a joint meeting of the Administrative Conference of the United States and the U.S. Chamber of Commerce, it appeared that the “stakeholders” he had mind were the Chamber’s members.
Globalization of regulations is always framed as a way to eliminate duplication and help business avoid regulatory burdens. But this executive order raises serious questions. Will it be the first step towards eroding America’s high standards, and weakening our safety protections? In the name of higher profits, will we be ceding our pre-eminent role as the leader of science-based regulation to the lowest common denominator?
How different things were 50 years ago. Then, in reaction to our narrow escape from the ravages of thalidomide, Congress strengthened the FDA. In 1962, Congress passed a law that required drug companies to prove a drug was both safe and effective, and this proof had to be based on science. What Congress did, Dr. Hamburg wrote, “not only benefited patients, they helped industry, raising scientific standards that eventually ushered in today’s sophisticated science-based life-sciences industry.”
Prompted by stronger rules, companies got serious about research and development, Hamburg observes. They started using clinical trials.
So all the drug companies went broke, right? Struggling under the burdens of job-killing regulations? Not quite. As Hamburg observes, the new powers for FDA “created a culture of innovation that laid the foundation for our current regulatory environment which fosters a domestic pharmaceutical industry that is second to none.”