Congress Raises Concerns about the FDA’s Ability to Protect Against Contaminated Foreign-Made Drugs UNITED STATES – According to an online news article published by Bloomberg.com, members of Congress raise concerns that the FDA is having difficulty protecting the American drug market from contaminated foreign-made drugs, such as Valsartan, Losartan, and other similar blood pressure medications. […]
Congress concerned about FDA failures
UNITED STATES – According to an online news article published by Bloomberg.com, members of Congress raise concerns that the FDA is having difficulty protecting the American drug market from contaminated foreign-made drugs, such as Valsartan, Losartan, and other similar blood pressure medications.
Over the past year, the country has learned that numerous versions of the blood pressure medications Valsartan, Losartan, and other similar drugs, had been contaminated with known human carcinogens. The United States Food and Drug Administration (FDA) has issued multiple recalls of these blood pressure drugs that are manufactured by many different pharmaceutical companies. The active ingredient in the contaminated blood pressure medications was manufactured outside the United States. The recalls of affected versions of these drugs have continued through the middle of 2019.
Members of Congress have raised concerns about the FDA’s capacity to test foreign-made substances that find their way into drugs sold throughout the United States. Specifically, some lawmakers question the FDA’s efforts to adequately inspect pharmaceutical manufacturing facilities throughout the United States to determine whether any drugs may be contaminated, posing a risk of harm to patients.
The House Energy and Commerce Committee is requesting information from the FDA regarding the recalls of various versions of Valsartan, Losartan, and other similar blood pressure medications tainted with probable human carcinogens. Additionally, this Committee is requesting information regarding a dispute between FDA senior staff and an inspector who inspected one of the manufacturing facilities of a pharmaceutical company that sold contaminated blood pressure medication.
The House Energy and Commerce Committee has also requested information on the FDA’s efforts to inspect domestic and foreign manufacturing facilities, and how the FDA decides which facilities to inspect. The Committee also requested unredacted documents from the FDA concerning the decision to recall the blood pressure medications contaminated with substances that have the potential to cause cancer.
