US Senator seeks “unannounced” FDA inspections of plants overseas | 16 August, 2019

In a letter sent to Alex Azar, secretary, Department of Health and Human Services (HHS), and Norman Sharpless, acting commissioner, US Food and Drug Administration (FDA), Chuck Grassley, chairman of the US Senate Committee on Finance, highlighted that the committee has an obligation to ensure that FDA upholds its responsibility to protect public health by properly overseeing the nation’s drug supply and ensuring that the drugs Americans use are safe and effective.

Referencing the valsartan drug safety issues that made headlines in the past year and an interview with ex-FDA investigator Motammed Masoud who “had tried to sound the alarm on what he flagged as potential systemic problems at two facilities in China and India that produce the API in generic valsartan and other blood pressure medications”, the letter also highlights that the “FDA only inspected one in five registered human drug manufacturing facilities abroad last year.”

As the Trump administration is pushing for drug imports from overseas in an effort to lower drug prices in the US, the letter states “the FDA does not track in its databases whether a foreign inspection was subject to an announced or unannounced visit.” Further, Grassley said he has learned that the FDA generally does not perform unannounced visits of drug manufacturing facilities in foreign countries but does perform unannounced visits at facilities based in the US.

The letter  goes on to mention that in 2013 the FDA created a pilot program in India that eliminated advanced notice and instead used short notice or unannounced visits. In 2015, the pilot program was shut down without explanation. It is unclear why the Obama administration shut the pilot program.

However, because of its reported successes, Grassley said he would strongly encourage the administration’s demonstration projects to include unannounced inspections in foreign manufacturing facilities to determine “if they meet the required API and drug quality and safety standards to include sufficient record-keeping, testing, and protections against counterfeiting”.

Meanwhile, following data accuracy issues with Novartis’ recently approved gene therapy — Zolgensma, Grassley has asked Novartis to provide details on data manipulation related to its US$ 2 million gene therapy.

Grassley wants Novartis to submit additional details, including the date when it came to know that it issued manipulated data to the FDA as well as the number of employees whose services were terminated due to this issue. Novartis said it has received the Senator’s letter and was reviewing the request.

(Source: PharmaCompass)