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# GOP Reps Challenge Generics from ‘Alert’ Firms
- URL: https://www.fdaweb.com/gop-reps-challenge-generics-from-alert-firms/
- Published: 2023-04-14T12:00:00.000Z
- Updated: 2026-09-14T18:25:43.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5154220

A 4/13 letter from five House Republicans is questioning FDA commissioner **Robert Califf** on agency safeguards in place when questionable foreign-made generic drugs are allowed to enter the country to prevent drug shortages. At issue is FDA’s decision to allow Glenmark Pharmaceuticals to import atovaquone from a facility that was under an import alert. The drug is used to prevent or treat a serious lung infection called Pneumocystis pneumonia.

“We are increasingly concerned that the choice facing Americans is to either have a supply of potentially unsafe generic drug imports from foreign manufacturing facilities that have violated FDA regulations or to have no supply of generic drugs at all,” the lawmakers [write in the letter](https://subscriber.politicopro.com/f/?id=00000187-7d08-d1c2-abc7-7d295e760001&ref=fdaweb.com). “In our view, this is an unacceptable choice. The FDA, along with Congress, must seek to resolve this crisis.”

The letter asks Califf to respond to the following questions:

- Does FDA have a procedure in place to ensure that hospitals and pharmacies are alerted that they have purchased products from a facility that the agency has placed under import ban, even if the manufacturer was later granted an exception?
- Does FDA test generic drug imports from facilities that have received a Warning Letter?
- Does FDA test generic drug imports from facilities that have been placed under an import ban and then later granted an exception?
- When a generic drug is in shortage, does the FDA have a procedure in place to identify a domestic manufacturer of that drug?
- When a generic drug is imported from a foreign manufacturer that has received a Warning Letter, does the FDA have a procedure in place to identify products made domestically?