Anthony Harrelson: Drug Regulations

Anthony Harrelson is the owner of his own Biopharmaceutical Company that has made it a person goal to help combat and cure HIV and Ebola. Many of the drugs and treatments that we take for granted today were developed by looking at past discoveries and experiments. Drug regulation acts and government control of drug standards have also helped to ensure public safety and the efficacy of new drugs. These were not always in place however, as at one point in time, in the United States specifically, revisions were trying to be made in the FD&C Act, which would result in many Congressional hearings. These hearings would cover the many different policy issues revolving around drugs at the time, including possible false advertising, the questionable efficacy of a drug, as well as a desperate need for more stringent regulatory methods by the industry at large.

While attempts for increased legislation and protection for consumers from the drug world were receiving much new momentum during this turbulent time, there were still many heated debates happening which were inhibiting anything from being done. It would take a tragedy to occur that would act as the final statement for those arguing for better and more comprehensive drug regulation. This tragedy would come in the form of an application for a new drug, thalidomide. This sedative had been marketed in Europe for quite some time now, however, an FDA officer in review did not believe that the drug was up to standard, and was not safe for public consumption.

This officer would continue to be coerced and encouraged to approve the drug, until it was suddenly pulled off the shelves in the German market as a result of it causing many birth defects. Thalidomide had caused thousands of newborns in Europe to be born with abnormalities, forever altering the course of their lives. While the drug was never officially approved in the United States, it was still distributed to many Americans as a preliminary study, causing about 17 birth defects.

Anthony Harrelson would read how this tragedy would cement the need for higher regulatory standards for drugs. From that point on, manufacturers would have to prove to the FDA that any drug they create was both safe and effective before it was allowed to be sold on the open market. The FDA would also be allowed to regulate how the advertising of a drug could be carried out, to ensure accuracy.

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