FDA Matters Blog

User Fee Reauthorization: FDA Is In Trouble If 2007 Repeats Itself

January 30th, 2012

Starting this week, the House will hold hearings on reauthorizing the drug and medical device user fee programs that fund one-fourth of the agency. While user fees have become largely non-controversial, this “must-pass” legislation is Congress’ opportunity to consider dozens of other FDA issues, some controversial and many time-consuming.

During the last user fee reauthorization in 2007, multiple non-user fee issues delayed enactment of a new law until September 27, just a few days before the start of the new fiscal year. In FDA Matters’ view, FDA is in serious trouble if it once again takes until September to complete the user fee reauthorization legislation.

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The State of the FDA—January 2012

January 24th, 2012

FDA is the only federal agency that touches the lives of every American several times every day. Its remarkably broad mandate includes all medical products and 80% of the nation’s food supply, plus countless other products. Despite this, when the President delivers his State of the Union (SOTU) address to Congress this week, it is unlikely that FDA will rate a mention.

FDA Matters will instead provide its second annual “State of the FDA.” As reflected in last week’s column, FDA did well in 2011, but one year’s progress does not change the continued precarious state of the FDA.

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Medical Innovation, Food Safety, and Imports: Did FDA Have A Good Year in 2011?

January 16th, 2012

Before turning to 2012, FDA Matters wanted to take one more look at FDA’s performance in 2011. So much happens at FDA that it’s easy to lose perspective. And no matter what the agency does, somebody will be unhappy. So, should Commissioner Hamburg feel good about the last 12 months?

FDA Matters thinks it comes down to how well FDA handled the three most important challenges it faced:
* improving the medical product review process, including stimulating innovation;
* implementing the Food Safety Modernization Act; and
* advancing the agency’s ability to assure the safety of imports.

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Post-Market Safety: Can Sentinel Do Some of the Heavy Lifting?

January 4th, 2012

To understand what happens to drugs under “real world conditions,” FDA has expanded its post-market efforts, including development of a monitoring system (called Sentinel) that will be able to track drug usage and medical history information on tens of millions of patients. Although such information will be useful, it can only provide post-hoc inferences, not proof of causation. Even with this limitation, FDA Matters thinks developing the system is worthwhile and may provide multiple benefits.

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Understanding FDA—Its Strength Is Its People

December 26th, 2011

Science is essential and rules and regulations must be followed…but ultimately it is the people of FDA who determine whether the agency functions well and acts in the best interests of the American people. For that reason, a recurrent theme in FDA Matters is the importance of FDA employees. Their jobs are much more difficult than most of us imagine.

Consider the oft-expressed paradigm: FDA is committed to science-based decisionmaking. Yet, science doesn’t exist in a pure, understandable, easily accessible and unassailable form. Neither do laws and regulations. While law and science are fundamental to FDA decisions, only people can actually make the decisions.

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FDA and Congress: Prospects for 2012

December 19th, 2011

Barely more than a year ago, the US experienced a “wave” election—sweeping a Republic majority into the House of Representatives and reducing the Democratic majority in the Senate. As a result, FDA faced a Congress in 2011 that contained fewer friends and less support than previously.

The consequences, thus far, have been small. Congress became so absorbed with deficit reduction that it accomplished little else this year and spent almost no time on FDA issues. Circumstances will change this in 2012 and, fortunately, we have strong clues about Congressional attitudes and priorities.

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Beyond Plan B: Scientific Integrity and a Possible Third Class of Drugs

December 12th, 2011

Patient access to the emergency hormonal contraceptive “Plan B One-Step” has been one of the most combustible issues ever faced by FDA. It received more attention last week when FDA approved expanded access for adolescents under 17 and HHS Secretary Katherine Sebelius promptly overruled the agency because she found inadequate scientific support for the decision. (For my readers outside the US, here is a New York Times article that provides background).

FDA Matters wonders: has FDA’s scientific decisionmaking authority been thwarted in some lasting way, as some have claimed? Is it time to reconsider proposals for a new category of drugs for which pharmacists are the gatekeeper?

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FDA Bashing: The Wrong Way to Improve FDA

December 5th, 2011

FDA is imperfect in many ways: it can be hard to predict, maddeningly slow to decide, and inflexible in the face of complex situations. Yet, FDA does remarkably well at carrying out its difficult public health mission. Plus, the agency is constantly striving for improvement.

These points seem lost on agency critics bent on bashing the agency. To believe many of them, FDA is bureaucratically and culturally driven to be ineffective…. and heedless of the impact of its actions on industry innovation and patients in medical need. FDA Matters says: nonsense!

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FDA’s Fuzzy Funding Future

November 28th, 2011

While not all of FDA’s problems are caused by a lack of resources, few of its problems can be solved without better funding. Money matters. “Safer foods” requires funding to implement the Food Safety Modernization Act. “Faster and safer drug and device approvals” are only possible with funds to pay additional reviewers and build improved regulatory systems.

FDA has an enormous job and its responsibilities grow every year. Funding increases over the last five years have not offset decades of underfunding and under-investment in the agency. FDA Matters believes the next 12 months will determine FDA’s funding future.

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Animal Research: An Update on One of FDA’s Core Values

November 22nd, 2011

The value of animal research in the life sciences is considered an NIH issue. FDA Matters believes that FDA and its stakeholders should be equally involved.

Animal research is the vital first step in the development of new medical products. Before any safety or efficacy testing is permitted in humans, FDA must be satisfied with animal testing data submitted by the product sponsor. Pick any medical breakthrough and you will find animals were tested prior to humans.

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