Shane Commentary

      

FDA Questions Safety of Pharmaceutical Products from India

Apr 14, 2017

    

Frequently the FDA had been criticized in the columns of CHICK-CITE and EGG-CITE for not adequately protecting U.S. consumers and patients with respect to foreign-produced generic drugs. This criticism has been used to justify the concept of unified food safety agency since it is maintained the FDA is ineffective with both regard to its responsibilities for food and for drugs.

  

Reuter’s reported that the FDA has issued a warning letter to a Mylan NV manufacturing plant in Nashik in the state of Maharashtra, India. The warning letter included the statement “Your quality system does not adequately ensure the accuracy and integrity of data to support the safety, effectiveness and quality of the drugs you manufacture.” In addition the FDA noted numerous violations including failure to “thoroughly investigate” unexplained discrepancies in drug batches and cited examples of “missing, deleted and lost data.” 

Mylan operates nine plants in India producing antiretroviral drugs used to suppress HIV. In 2015 the FDA sent warning letters expressing concern over quality control at three Mylan facilities in the city of Bengaluru.

With respect to pharmaceutical products, any deficiencies in operation should be regarded in a serious light and should result in more than a warning letter, especially in view of the fact that the company has been cited for discrepancies on previous inspections. These occur at infrequent intervals. There does not seem to be a reason why the FDA should not place the Plant on an embargo list since this will certainly protect U.S. consumers from substandard product and at the same time bring about urgent improvements.

The FDA is not fulfilling its obligations to consumers and despite receiving increased funding appears to favor pharmaceutical manufacturers possibly as a consequence of the “revolving-door” syndrome. By its own admission, the FDA only inspects less than two percent of imported food. Given that the Agency does not appear to be effective in surveillance of either food or drugs, it should relinquish food and concentrate on what it is apparently best equipped to control.