The US Food and Drug Administration (FDA) has cleared previously banned Chinese pharmaceutical companies to manufacture drugs in an effort to avert a cancer treatment shortage. Major pharmaceutical companies source around 80% of all ingredients to make drugs from China and India, according to reports. While sourcing the materials from foreign countries saves pharmaceutical manufacturers on production costs, the concern of little to no oversight for product safety raises concerns for US patients.
The decision to allow banned Chinese manufacturing plants to supply ingredients for cancer drugs comes after the FDA placed restrictions on Zhejiang Hisun Pharmaceutical Co for deleting sensitive information about the potency and purity of drugs. However, restrictions placed on Hisun were lifted and ingredients from the plant are now used in to make chemotherapy drugs to prevent a critical a shortage in the U.S.
FDA Regulations & Safety
The FDA is responsible for enforcing standards in pharmaceutical manufacturing to ensure the effectiveness and safety of drugs. The real challenge of this task comes with regulating pharmaceutical manufacturing plants overseas. Language barriers, along with the cost associated with the oversight of manufacturing plants, are just some of the troubling aspects of this task. The FDA makes announced and unannounced inspections of drug plants to check that the conditions meet manufacturing standards and are safe for production. When the FDA finds safety or regulatory issues within an audit, such as the Zhejiang Hisun case, the plant can be banned from producing compounds for pharmaceuticals sold in the US.
Faced with the potential of a cancer drug shortage, the FDA lifted restrictions placed on Hisun and is now exporting key ingredients needed to manufacture chemotherapy drugs. Drug plants can have these restrictions lifted by correcting errors and following protocols set by the FDA. Considering the risk for delaying cancer treatments for critically ill patients, this compromise by the FDA highlights the need for US-based pharmaceutical companies to reduce their dependence on overseas manufacturers and suppliers for therapies.
Reporting Drugs to FDA
Drug companies encourage patients to report side effects to doctors to help keep track of potential quality issues. The FDA allows consumers to report problems related to serious side effects, product quality, and failure of therapies online. Taking small actions such as these can help identify drugs that may be ineffective and force pharmaceutical companies and the FDA to take action to inspect manufacturing issues and enforce standards.