Pharm Exec Q&A: A Soft Spot for Whistleblowers - Pharmaceutical Executive


Pharm Exec Q&A: A Soft Spot for Whistleblowers
FDA's most aggressive critic in Washington is Iowa Senator Charles Grassley. In this exclusive Pharm Exec interview, he explains where the agency goes wrong—and what he would do to fix it.

Pharmaceutical Executive

What should the pharmaceutical industry do to improve the regulatory system?

I wouldn't go so far as to accuse them of interfering. But they see FDA as their little clubhouse. It's part of this culture I'm talking about. The culture has to work to protect John Q. Public and not be a facilitator for the industry.

I think the industry is the greatest in the world. And we ought to keep it that way. But just like any industry where your product could be unsafe, it's the government's responsibility to ensure that it's safe and effective. If they do their job, we'll end up with great advances for human medicine.

Common Sense Iowan

Charles Grassley takes pride in being "a workhorse, not a show horse," a "common-sense conservative" who values integrity and tenacity. He boasts that he is the only working farmer in the US Senate (his son runs the family farm now) and that he brought his Iowa work ethic to the nation's capital. He has five children and many grandchildren and has been in the Senate since 1980. He focused on health and prescription-drug issues as chairman of the Senate Aging Committee in the late 1990s, before taking the helm of the Finance Committee five years ago.

One important accomplishment as Finance Committee chair was moving forward the Medicare Modernization Act, which Congress enacted in late 2003 to bring "Medicare into the 21st century." This established the Medicare prescription drug benefit and also extended health plan options to rural areas, a central issue for the senior Senator from Iowa.

Throughout his political career, Grassley has emphasized the importance of Congressional oversight to root out government mismanagement and corruption. In the 1990s he waged a campaign to obtain documents on missing POWs and went after the IRS, the FBI, and the Defense Department. He has investigated fraud involving Social Security payments, waste in the Medicaid program, and neglect in nursing homes. He champions whistleblowers and pushed for the whistleblower protection laws of the 1980s—measures that generated much of the ammunition he uses today to blast FDA management, culture, and policies.


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