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Commissioner Scott Gottlieb exits USFDA, Indian firms curious on agency’s future course

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Scott Gottlieb, Commissioner for the US Food & Drug Administration, has announced he will be stepping down next month. This has raised curiosity among Indian drug makers on who will replace him and whether there will be continuity in some of the policies implemented by him.

The reasons behind Gottlieb’s exit are attributed to his personal commitments.

An executive at an Indian pharmaceutical company termed Gottlieb’s tenure ‘action packed’ in terms of speeding up of approvals and measures to bring in generic versions of complex drugs.

“There was more certainty on the direction of the agency, it’s interesting to see who will replace him,” the executive added.

The regulator’s actions impact Indian drug makers, who generate significant revenues by selling copycat drugs at a fraction of the cost in the world’s largest market for medicines.

India drug companies exported medicines worth about $5.1 billion in FY18, constituting 30 percent of total exports.

Exit may benefit Indian pharma
Gottlieb, who is considered to be one of the few successful high profile appointments of the Trump regime, tried to fix the problem by forcing competition.

In the last two years USFDA approved a record number of generic drugs. In 2017, it permitted a record 844 generic drugs, a 36 percent jump compared to previous year. Indian companies alone accounted for 42 percent of all those approvals.

In 2018, USFDA approved 810 generic drugs, of which India’s share was 40 percent.

Well, a higher number of approvals aren’t necessarily good news for Indian generic drug makers as it meant additional competition and much lower realisations at a time when the trade was impacted by consolidation of buyers and distributors in the US.

The other move that Indian drug makers appreciate is Gottlieb’s efforts to bring low-cost generic versions of complex drugs such as inhalation drugs, transdermal patches, injectables and biosimilars faster to the market, which have evaded competition.

Complex generics are drugs that by nature of their formulation or delivery systems are harder to copy under traditional approaches. As a result, these drugs often face less competition and are expensive.

USFDA released guidance for dozens of such drugs, providing clarity on what the regulator expects from a generic filer when they file for such product.

Natco Pharma (copaxone approval) and Biocon (Pegfilgrastim and Trastuzumab) are some of the Indian drug makers that have benefited from Gottlieb’s efforts to bring complex and biosimilar products faster to the US market.

Gottlieb, a good communicator, was active on Twitter. He was also vocal critic about some of the anti-competitive practices adopted to thwart competition.

Branded drug makers are known to use citizen petitions and making it extremely difficult for generic drug makers to access samples of the original drug product.

Trump appointeeGottlieb took over as the Commissioner of USFDA in May 2017, months after Donald Trump took charge as President of the United States.

Trump had vowed to reduce prices of prescriptions drugs in his presidential election campaign.

Spiralling costs of prescriptions drugs is a major political issue in the US, where expenditure on healthcare constitutes 18 percent of the country’s gross domestic product.

But Trump’s options are limited as past governments have traditionally restrained from directly fixing market prices, an anathema of free trade that they championed so dearly for decades.



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