Howard Sklamberg Talks to The Hindu Business Line About Indian Pharma and FDA Warnings

Akin Gump health care and life sciences partner Howard Sklamberg was quoted by The Hindu Business Line for its article “Indian drugmakers are going up the quality ladder,” on the perception that India’s pharmaceutical industry is improving the quality of its documentation and data after years of criticism from foreign drug regulators.

Sklamberg, who previously served as the Deputy Commissioner for Global Regulatory Operations and Policy at the U.S. Food and Drug Administration (FDA), said in response to this perceived evolution of India’s pharma industry, “A drop in the percentage of 483 observations or warning letter citations mentioning data integrity does not indicate that the FDA has shifted priorities. The agency’s priorities remain the same, but it is finding a smaller percentage of data integrity violations even though it is a priority.”

As a possible takeaway from the reduction in warning letters, he noted, “I would hesitate to draw too large a conclusion from one or two years of data. The number of warning letters FDA issues is relatively small, so it is possible for percentages to vary a lot based on just a few inspections. The best indicator is a long-term trend. But the reduction is encouraging.”

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