The US Food and Drug Administration has warned that it is considering tightening controls on generic drugs so that there is “less variability” with their brand-name counterparts.
The agency has heard claims of a lack of therapeutic equivalence with generics from patients and employees of generic drugmakers, Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research (CDER) told the Fall Technical Conference held last week by the FDA and the Generic Pharmaceutical Association (GPhA).
“I’ve heard it enough times from enough people to believe that there are a few products that aren’t meeting quality standards,” said Dr Woodcock. “They say: ‘I know there are products out there that aren’t equivalent,’ and typically they’re manufacturing folks,” she told the meeting.
In April, the FDA’s advisory Pharmaceutical Science and Clinical Pharmacology Advisory Committee told the agency that its current equivalence requirements were insufficient for a number of drugs. However, in a statement on Dr Woodcock’s comments, the GPhA said that the FDA’s “demanding generic review and approval procedures for generic drug applications are the gold standard for regulatory agencies around the world.”
“As the FDA has repeatedly stated about therapeutic equivalence: ‘a generic drug must be shown to be bioequivalent to the reference [brand] drug. Through review of bioequivalence data, FDA assures that the generic product will perform the same as its respective brand name (or reference) product,’” says the trade association.
It goes on to note that three billion of the four billion prescriptions dispensed in the US this year will be filled with FDA-approved generic drugs. “Generics enable consumers to meet their medicine needs at a cost of up to 80% less than what they would have to pay if generics were not available,” and they save the US health care system “$1 billion every three days,” said the GPhA.
It is not yet clear what impact the FDA’s proposals might have on the Indian drug industry, which is one of the USA’s biggest suppliers of generic medicines. Indian drug exports to the US totaled some 87 billion rupees ($2 billion) last year and accounted for more than a quarter of the Indian industry total exports worldwide, according to figures from the Indian government’s drug export agency, Pharmexcil.
Depending on the degree of additional quality control and new requirements which the FDA might be seeking, the proposals could mean higher costs and lower profits for Indian exporters, according to Ernst & Young analyst Muralidharan Nair, commenting for the Economic Times of India on Dr Woodcock’s remarks. Margins on some products in the US are even lower than in India, he added.
