It has been reported widely that there is a great deal of “outsourcing” in manufacturing and technical support. But beyond the economic impact of sending jobs overseas, this practice could now be impacting the safety of prescription medicines. Some of the world’s largest drug companies are taking the concept a step further, farming out safety monitoring to companies based in India. AstraZeneca PLC, Novartis AG, and Bristol-Myers Squibb Co. are among the big names sending their pharmacovigilance operations overseas. Drug safety company Accenture PLC says its drug safety business has tripled in the last three years.
Before a new drug is approved, it must go through clinical trials. These trials are designed to show how well the drug works, and what sort of risks come with it. Premarket trials include an average of 1,500 patients. However, rare side effects might not show up until 100,000 or more patients are exposed to the drug. Even drugs that have been on the market for years can have unknown and potentially deadly side effects.
Because of this possibility, manufacturers have a responsibility to continue collecting safety information about the drug after it is on the market. This monitoring takes the form of adverse event reporting. Patients and doctors contact the drug company to report side effects they experience while taking the medication. The company collects that information and enters it into a database. Drug companies and the U.S. Food and Drug Administration (FDA) then use that information to look for safety signals — patterns that show a connection between problems and a particular drug or combination of drugs.
Monitoring for safety signals in the pool of adverse event reports is a lot like looking for a needle in a haystack. Safety reviewers must have expertise in medicine, biochemistry, and pharmacology. Accenture, which runs its drug safety operation out of India, says that its reviewers are qualified and have gone through rigorous training. Moreover, they say, they have actually sped up the reporting process.
However, despite their training and qualifications, doctors and scientists employed by outside companies are likely missing key expertise on the specific products they are reviewing. They simply do not have as much knowledge about the company’s products as an in-house team. According to Scott Bass, a lawyer at Sidley Austin LLP who advises drug companies on compliance issues, “You can’t compare the quality of a full in-house multinational pharmacovigilance team with an outsourcing company.”
The stakes couldn’t be higher. Adverse drug reactions are the fourth leading cause of death in the U.S. Quality pharmacovigilance work is crucial to making sure that doctors and patients have the most complete and accurate safety information about the medications they use.
Sources: fda.gov; wsj.com
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