What makes a strong FDA?

Innovation2 President Obama this week ordered a review of US regulations, including those implemented by the Food and Drug Administration, to ensure a proper balance between protecting consumers and promoting innovation in the economy – two concepts that are sometimes believed to be at odds with each other.

But we at AstraZeneca believe that vibrant innovation and protecting consumers and patients need not be mutually exclusive, and the president is to be commended for having his agencies examine the issue.

In fact, people are sometimes surprised to learn that we favor a strong FDA overseeing the pharmaceutical industry in the United States. We do so because a strong regulator is good for patients and good for health – and that’s ultimately good for our company.

What does a “strong regulator” look like? As the administration conducts its review, we believe the FDA must be:

1. Well-funded so it has the resources to do the best job in a reasonable timeframe.

2. Scientifically world-class with the appropriate scientific, clinical expertise in relevant fields.

3. Independent, and confident to make benefit/risk assessments based on the science and patient
need alone.

4. Clear in its communication, and consistent in the application of its principles.

By meeting these four benchmarks, the agency will provide the regulatory framework to encourage innovation while looking out for patients.

To help give the FDA the tools it needs, AstraZeneca is a member of the Alliance for a Stronger FDA – a coalition of patient, consumer, industry and other organizations dedicated to increasing funding for the agency. As we noted earlier, AstraZeneca has urged the Obama Administration to give the FDA a 20 percent increase for the fiscal year 2012 budget.

We also asked this question over at Quora: What are the elements of a strong FDA?

– By Tony Jewell