This year marked two important anniversaries in the regulatory community. In the US, regulators noted the 50th anniversary of the passage of the Kefauver-Harris Amendments to the Federal Food, Drug and Cosmetic Act (FD&C Act), a piece of legislation aimed at improving regulatory oversight over healthcare products. Worldwide, regulators marked a more ominous anniversary: 50 years since the drug Thalidomide was introduced to the world.
The introduction of the drug is one of the defining moments in the history of regulation. Intended as a means to treat morning sickness in pregnant women, the drug's teratogenic effects caused horrific birth defects, killing many of its victims and leaving survivors severely disabled. While the drug never made it to market in the US thanks to the now-legendary efforts of FDA scientist Frances Kelsey, it was introduced to patients in the EU, where its effects are still being felt today.
For decades, the original manufacturer of the drug, the Grünenthal Group, refused to apologize, arguing that it had "acted in accordance with the state of scientific knowledge and all industry standards for testing new drugs that were relevant and acknowledged in the 1950s and 1960s." The company, remarked Harald Stark, CEO of Grünenthal, could not detect the drug's teratogenic effects at the time.
For victims of the drug, an apology from Grünenthal would be 50 years in the making. The company finally issued a statement earlier this year saying that it acknowledged its "responsibility" for the incident, and noted that "projects and initiatives" would be forthcoming. Many victims, however, called it an empty gesture, saying it did not admit nearly enough responsibility for the incident and was insufficient to compensate them for the years of care that they have required.
Now, compensation is finally on its way-but not from Grünenthal. The Guardian and Pharma Times both report that the UK government's Department of Health will set up an £80 million fund to disburse payments to the 325 remaining English survivors of Thalidomide over the next 10 years, with the funds to be administered by the Thalidomide Trust. An additional 106 survivors in Scotland, Wales and Northern Ireland are not covered by the arrangement, notes The Guardian.
"This deal represents our clear acknowledgment that thalidomiders should be supported and helped to live as independent lives as possible, and we hope that this grant will aid that cause and provide an element of long term financial security," said Norman Lamb, minister of state at the UK Department of Health.