September 26, 2013
Margaret A. Hamburg, M.D.
Food and Drug Administration
10903 New Hampshire Ave
Silver Spring, MD 20993-0002
Dear Commissioner Hamburg,
As members of the Patient, Consumer, and Public Health Coalition, we strongly support the FDA’s ban on importing drugs manufactured at Ranbaxy Laboratories, Ltd.’s facility in Mohali, India. The company’s facility is not complying with current good manufacturing practices (cGMP), which are the main regulatory safeguard to ensure drug manufacturing quality.
The public was shocked to learn of the repeated cGMP violations at Ranbaxy’s facilities in several countries. Most physicians and their patients would have avoided Ranbaxy’s generic drugs had they known of these problems dating back until at least 2008.
It is comforting to know that Ranbaxy pleaded guilty on May 13, 2013 to felony criminal and civil charges relating to adulterated drugs, and received criminal fines of $150 million and civil fines of $350 million.1 However, Ranbaxy’s adulterated drugs had already been distributed to tens of millions of Americans for a variety of treatments including epilepsy (gabapentin) and bacterial infections (ciprofloxacin). Adulterated ciprofloxacin may have added to antibiotic resistance problems in the United States.
We support the FDA’s increased scrutiny of Ranbaxy’s facilities in India. However, given Ranbaxy’s criminal history and its past behavior of making false statements to the FDA, we do not support Ranbaxy’s hiring of “a third-party expert to conduct a thorough inspection” of its Mohali facility. If this company chooses its own inspector, it would be impossible to trust the results. The medical community and the public need reassurance that generic drugs are truly equivalent to brand name drugs, and that requires that the FDA conduct the inspections to ensure compliance with cGMP requirements, rather than a third-party. Also, since the FDA does not anticipate that banning of imports from Ranbaxy will cause a drug shortage, the agency should be thoroughly satisfied that Ranbaxy has complied with cGMP before allowing it to resume manufacturing of FDA-regulated drugs from its Mohali facility.
As you know, the doctors’ and public’s trust in generic drugs makes it possible to save billions of dollars in health care costs while providing excellent medications. If their trust is eroded, healthcare costs would skyrocket. For that reason, it is essential that the FDA remain firm in its regulation of Ranbaxy and other generic manufacturers.
Thank you for your continued vigilance in this matter.
American Medical Student Association
American Medical Women’s Association
Breast Cancer Action
Community Access National Network
Connecticut Center for Patient Safety
Jacobs Institute of Women’s Health
National Consumers League
National Research Center for Women & Families
National Women’s Health Network
Our Bodies Ourselves
The TMJ Association
Center for Science and Democracy, Union of Concerned Scientists
- United States Department of Justice (May 13, 2013). Generic Drug Manufacturer Ranbaxy Pleads Guilty and Agree to Pay $500 Million to Resolve False Claims Allegations, cGMP Violations and False Statements to the FDA. Press Release. http://www.justice.gov/opa/pr/2013/May/13-civ-542.html ▲