Bloomberg stories on risks of generic drugs has Gottlieb justifying inspection focus and strategy

By PharmaCompass

2019-02-07

Impressions: 114 Article

Last week, Bloomberg carried a series of news features on the risks facing America’s generic drug industry. One report was on how America’s love affair with cheap drugs has a hidden cost; and that data, documents and interviews show how a focus on cutting prices has come with risks to consumer health.

The second feature is on the sartan impurities issue. It talks about how a heart drug made in China by Zhejiang Huahai Pharmaceutical, and taken by millions of people, was contaminated with a possible cancer-causing chemical.

The third feature was on India’s culture of bending rules, and how it is challenging the FDA. The fourth feature was on the US$ 4.3 billion Fresenius SE-Akorn Inc deal that fell through over shoddy drug production. After Fresenius offered to buy Akorn, it uncovered a litany of problems.

“The takeover’s collapse and the resulting courtroom battle left behind a public accounting of just how wrong things can go in the complicated process of making generic drugs. The record illustrates how investors can lose billions—and doctors and patients can lose trust in lifesaving medicines—when that process is broken,” the Bloomberg feature on the failed Fresenius-Akorn deal said.

In reaction to the Bloomberg stories, the US Food and Drug Administration (FDA) commissioner Scott Gottlieb took to Twitter to justify the agency’s inspection focus. Gottlieb said in a tweet: “Total generic manufacturing inspections increased meaningfully in 2017 and again in 2018. The scope and strength of our overall oversight footprint grew substantially; evidenced by a sharp rise in enforcement actions in 2017-18 that we will publish details on in the next two weeks.”

Gottlieb also defended generic drugs in another tweet: “Generic drugs provide tremendous public health benefit by promoting access and affordability. They’re subject to rigorous standards and are just as safe and effective as brand counterparts. Our oversight of generic manufacturing has been strengthened substantially under GDUFA.”

“FDA is only as good as the data that manufacturers submit to it,” David Kessler, the FDA commissioner for most of the 1990s, said in an interview to Bloomberg. “Yes, the agency can audit data, it can do inspections, but it’s not going to catch everything.”

In another tweet, Gottlieb said: “We’re putting out data soon on our overall footprint when it comes to oversight of generic drug manufacturing; but inspections are up, so are enforcement actions related to inspectional activities, reflecting the expanding scope of our overall supervision.”

In response to the story on regulatory lapses in India, Gottlieb tweeted: “…generic inspections in India have risen, but geography isn’t a factor in risk-based targeting. Our inspection model more carefully calibrates ALL risk factors.”

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