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FDA and Election 2010: Oversight and Investigations

The return of a Republican majority in the House of Representatives means an increase in Congressional oversight and investigations. This mirrors 2006, when the Democrats took back Congress and immediately started investigating the Bush administration.

President Obama’s election and the distraction of the health reform debate have helped us forget the impact of divided government on FDA. Once again, the agency will find itself buffeted by political forces that are as concerned about "scoring points" as they are about improving government. FDA Matters thinks this will have a large impact on FDA, as well as the agency’s stakeholders.

In the House of Representatives, there are three committees that exercise "oversight and investigations" jurisdiction (O&I) over the FDA. The primary ones are the Energy and Commerce Committee and the Oversight and Government Reform Committee. The Appropriations Committee also conducts O&I.

The Energy and Commerce Committee intends to investigate the scope of work and expenditures under FDA’s contract with McKinsey & Company, an international management consulting firm that has been asked to improve the productivity of the generic drug review office. Once the Energy and Commerce has reorganized itself for the new Congress and priorities are set, there are sure to be more areas under investigation.

The Oversight and Government Reform Committee is off to a faster start because outgoing chair Representative Edolphus Towns (D-NY) and incoming chair Representative Darrell Issa (R-CA) were already working together on manufacturing problems in the drug industry. This has now become an investigation of whether understaffing in FDA’s Puerto Rico office led to inadequate oversight of industry.

FDA is under scrutiny all the time. Congress’ watchdog arm, the General Accounting Office (GAO), regularly reports on areas where they believe FDA should do better. Likewise, the HHS Inspector General keeps a watchful eye on the agency. In a more helpful, but often no less critical mode, the Institute of Medicine also oversees many aspects of FDA programs.

What may make 2011 different?

Dr. Hamburg and Dr. Sharfstein can expect to spend countless more days preparing for and testifying at oversight hearings. Their involvement is the tip of the iceberg, with staff at every level being pulled from other work to respond to Congress. Some key staff that were able to focus on big picture issues this year…are likely to be in "damage control" mode most of next year.

FDA’s competence will be questioned publicly, then magnified by the media. FDA has a lot of problems. Oversight can contribute to improvements. However, any loss of public confidence in FDA is a serious barrier to the agency doing its job better.

This may also lead to questions about whether the agency should receive more monies….when, in fact, many of the problems (not all of them) cannot be fixed without more resources. For example, unless you believe there are FDA staff sitting idle, how does understaffing in FDA’s Puerto Rico office get resolved without a larger appropriation?

Oversight of food safety may lead to more effective use of resources, but cannot obviate the need for more inspectors. Oversight of medical products may lead to more conservative decisions by the agency, further slowing new therapies for patients.

As oversight of FDA ramps up, so too will oversight of industry. FDA Matters has exhorted CEO’s to see quality controls, good manufacturing and improved sales and marketing practices to be integral to whether its products represent a public good. O&I is likely to be unflinching in its exposure of those who have not taken this to heart.

In the end, FDA will survive. Hopefully, it will be a better agency, while preserving its needed funding growth. Meantime, it is inevitable that FDA and industry will feel some pain.


My apologies to readers who may have received more than one mailing last week. The end of daylight savings time caused repeat distribution of several columns. Hopefully, it is now fixed.

 FDA and Election 2010: Deficit Reduction and Appropriations      November 7th, 2010

So–called "wave elections"–where one party overwhelms the other–are particularly hard to judge. The ground rules are going to change dramatically– in ways that no one can fully anticipate. At first, each side refuses to compromise. Then, something happens that sets the pattern for whether people will work together and on what issues. This may take months to resolve or may occur before the new Congress arrives. As things change, FDA Matters thinks there are some key issues for FDA-watchers to monitor. Read the rest of this entry

Quality Control Woes: What’s a CEO to Do?    June 2nd, 2010
Medical products companies are struggling to assure FDA and the American people that their products are "safe as manufactured and distributed." We don’t know whether quality control has become lax, FDA is discovering more problems or industry has just had a run of bad luck. We do know that quality control relies on a lot of people maintaining tough standards…and that manufacturing is rarely a priority of a drug and device company CEO. FDA Matters asks: "what’s a CEO to do?" Read the rest of this entry

Black, White, Shades of Gray      November 13th, 2009
Civil and criminal investigations are becoming a more prominent feature in the world of FDA-regulated industries. People who never gave any thought to this….suddenly find themselves needing to understand how investigations work. Being FDA-regulated means "always worrying that you will have to say you’re sorry." But it matters whether you are apologizing to FDA or trying to apologize to investigators. Read the rest of this entry

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