Thalidomide Victims Appeal to US Lawmakers to Preserve Safety Regulations in the US on Thalidomide and Other High-Risk Drugs

Friday, February 2, 2018 Drug News
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PETERBOROUGH, England, Feb. 2, 2018 /PRNewswire-USNewswire/ -- The Campaign for the Prevention of Thalidomide Births in Europe,

representing victims of the thalidomide tragedy of the 1950s and 1960s, has appealed to the US Congress not to set back efforts to prevent harmful exposure to thalidomide and drugs that cause terrible birth defects by passing the ''Creating and Restoring
Equal Access to Equivalent Samples Act" in its present form.

Intended to spur the development of lower-cost generic drugs in the US, CREATES would force pharmaceutical manufacturers to sell samples of dangerous medicines regulated with Risk Evaluation and Mitigation Strategies (REMS) to generic companies for drug development. This includes thalidomide and its chemical analogues, now used in cancer treatments.

Addressing the possible safety consequences of CREATES, organizations representing thalidomide victims in Belgium, Italy, Spain and the United Kingdom sent a letter dated 31 January to Senators Mitch McConnell and Chuck Schumer and House leaders Paul Ryan and Nancy Pelosi urging lawmakers to "learn from the mistakes made in other countries" by not weakening the REMS program. The letter is available at:

The concern, shared by the European Medicines Agency (EMA) and the Medicines and Healthcare products Regulatory Agency (MHRA) in the UK, is CREATES will do away with established procedures whereby both innovator and generic manufacturers are held to the same safety requirements when testing and distributing dangerous drugs.

Glenn Harrison, chairman of The Campaign for the Prevention of Thalidomide Births in Europe, himself a thalidomide victim, represented the remaining survivors who urge US policymakers to balance the economic benefits of generic drugs against the safety consequences of inadequate controls on dangerous drugs like thalidomide.

"Although we are patients ourselves and appreciate the economic benefits afforded by generic drugs, when safety, and more importantly, control are as vital as with compounds like thalidomide, the consequences of inadequate protections greatly outweigh any projected cost savings.  Recent experiences in Brazil, Africa and India, where thalidomide babies continue to be born, firmly underscore this point and highlight exactly what can occur if a medication like thalidomide is not tightly controlled."  

Marketed outside the US in the 1950s and early 1960s to treat morning sickness during pregnancy, thalidomide was responsible for one of the worst public health tragedies of modern times. From 1956 to 1962, as many as 10,000 babies were born with major malformations, such as severely shortened arms or legs and flipper-like hands or feet. An estimated 3,000 thalidomide victims remain alive today.

About The Campaign for the Prevention of Thalidomide Births in EuropeFounded by Glenn Harrison, a thalidomide victim, The Campaign for the Prevention of Thalidomide Births in Europe holds to account the regulatory bodies across Europe to ensure that agreed pregnancy prevention programmes to prevent harmful exposure to thalidomide. Glenn also lobbies for strict thalidomide regulations in Asia and South America where thalidomide babies continue to be born.

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SOURCE The Campaign for the Prevention of Thalidomide Births in Europe

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