Gottlieb, 46, who resigned in the middle of his tenure in March this year, has been tweeting to convince patients that generic drugs are safe, a move that should boost the image of several manufacturers, including Indian pharma companies that have been criticised in the past for poor quality standards.
“I take generic drugs and have extreme confidence in them. I prescribed them to help my patients achieve value in their healthcare,” he tweeted on May 13. “Some bad problems arose years ago. We learned from them; and responded. Today’s generic drug framework is vigilant and upholds FDA’s gold standard.” Nearly 90% of medicines that American patients take are non-branded generics. Across the world, they have become one of the key means of providing accessible healthcare, being cheaper than branded drugs.
“I wouldn’t say Gottlieb is taking our side. He is speaking for the wellbeing of patients and we also believe that patients’ safety is of utmost importance for us,” said Sudarshan Jain, director general of the Indian Pharmaceutical Alliance (IPA), a lobby group of leading Indian drug companies.
The former FDA commissioner, who’s a physician, said generic drugs approved by the US FDA are safe and effective and equal to their branded counterparts, and though the generic industry has faced challenges, much has changed in last decade. For one thing, the regulator’s oversight has vastly expanded, he said.
In the past few years, the FDA has hired more than 1,000 people to work on generic drug issues. Inspections are up significantly, as are warning letters. This reflects the increased oversight and strength of the FDA’s generic programme. The Generic Drug User Fee programme has helped to vastly expanded regulatory scrutiny, Gottlieb tweeted.
Gottlieb’s comments came amid social media chatter over a new book by journalist author Katherine Eban, which documents poor manufacturing practices followed by generic drug companies in eight countries, including India.
Indian generic makers such as Sun Pharmaceuticals, Lupin and Dr Reddy’s built their fortunes over a decade ago during the US generic gold rush. But they faced a setback after Ranbaxy Laboratories (now part of Sun) was indicted in a Department of Justice (DOJ) investigation over falsification of data and suppling poor quality drugs to US patients in 2013.
As a result, scrutiny increased significantly. Gottlieb said that the FDA’s total pre-approval and surveillance inspections in China rose from 19 in 2007 to 153 in 2018 and in India from 66 in 2007 to 252 in 2018.
The US healthcare system has benefitted to the tune of $2 trillion in savings from generic drugs in the last decade. Of that, $293 billion came in 2018 alone, according to a report by consulting firm IQVIA Institute for Human Data Science.
In the last decade there has been a significant improvement in the quality culture of Indian companies, IPA’s Jain said. Recent audits of Indian companies have shown they can be compared with the best in the world and this is also the reason why exports to US have grown, Jain said.