FDA “Exceptionalism” at the Funding Crossroads
May 2nd, 2011The 15-month long battle over the nation’s fiscal year (FY) 2011 budget was finally resolved on April 16, just before Congress recessed. Despite broad pressures for program cuts and deficit reduction, the FDA received a $107 million increase, one of the few winners among domestic federal agencies.
Congress returns at the beginning of May to start the FY 12 appropriations process. Downward pressure on federal spending will intensify. If, despite this, the FDA receives another increase, then it will move closer to establishing itself as an exception to the budget cutting process. Thus, FDA Matters sees the coming funding battle as a crossroads for FDA.
Read the rest of this entryWhen an Investigator Knocks on Your Door
April 11th, 2011The last Congress was dominated by the economy, health reform and the election campaign. Congressional oversight and investigations (O&I) never gained much traction. So far this year, appropriations and budget have dominated Washington. Not much other work has been done.
FDA Matters thinks this will change soon. Without money to spend on new programs and no interest in legislating new regulations, most committees have little else to do other than O&I. As a result, FDA and FDA-regulated industries can expect a lot of attention from Congressional investigators. Even without Congressional prodding, FDA, the Department of Justice, and Inspector Generals are likely to be doing more investigations.
Read the rest of this entryPublic Incentives and Drug Development: More is Usually Better
April 5th, 2011A former colleague often declared: life sciences companies have no alternative to re-investing in developing more drugs, biologics and medical devices. I always thought this naïve because of its implication that life sciences research is self-perpetuating and does not need encouragement.
Currently, Congress seems primed (through oversight and possibly legislation) to consider the role of companies and government in medical product development. This week, FDA Matters explores the nature and need for incentives to conduct life sciences’ research; last week’s column looked at issues surrounding the pricing of medical products.
Read the rest of this entryDrug Product Pricing 101
March 26th, 2011A thousand good deeds of the pharmaceutical and biotechnology industries have been washed away by the decision of K-V Pharmaceuticals to charge $1500 per dose for Makena, a drug that reduces the risk of pre-term delivery in pregnant women. There is an easy comparator: the same therapy has been compounded in pharmacies for years at a cost of $10 to $30 per dose. Congressional and public reaction has, quite understandably, been one of outrage.
No one knows the right price for this drug, but there are ways to find out. In conversations this week, FDA Matters discovered that many knowledgeable people don’t know that there are tools to rationally evaluate and guide product pricing decisions.
Read the rest of this entryForget the Hype: Change Takes Time
March 21st, 2011FDA Matters is always impressed by how much FDA does. The everyday tasks are overwhelming: reviewing, approving, monitoring and inspecting the products and facilities responsible for 80% of our food supply and 100% of drugs, biologics, medical devices, vaccines, and animal drugs. Then there are the policy issues, big and small, that must be tended to.
These are largely functional tasks—someone has a job (or several) and does them. Yet, FDA has another life, as the bridge to the future of foods, drugs and devices. This responsibility is vitally important to our nation. It also takes time to bear fruit.
Read the rest of this entryFDA and Its Regulated Industries: A Cornerstone of America’s Economic Future
March 7th, 2011On March 7, the Alliance for a Stronger FDA released a white paper on the far-reaching and positive economic impact of a strong FDA and the industries it oversees. The report is intended to provide interested parties, including Congress and Executive Branch policymakers, with information on FDA’s role in economic growth. A number of groups–consumers, patient advocates and industry–provided comments to the Alliance on the impact of FDA on the American economy.
Read the rest of this entryFDA Is Fighting on Two Fronts
February 27th, 2011FDA is still a 20th century agency. It lacks the databases, technologies and tools to do its work. It does not have the depth of manpower to be experts in all the increasingly complex sciences associated with medical products and foods. It lacks the confidence to consistently make decisions based on risk-benefit analysis, rather than leaning toward the highly restrictive Precautionary Principle.
FDA Matters can’t see any downside to the FDA gaining the technology, the manpower and the confidence to transform itself into the 21st century FDA that our nation needs. Yet, Commissioner Hamburg has to fight on two fronts to preserve her ability to make the necessary changes.
Read the rest of this entryFDA and Congress: FY 11 Deficit Reduction Could Cut Deep
February 13th, 2011Two upcoming events this week will set the tone for FDA appropriations for the next two years. On Monday, the President will release his request for FY 12 funding. On Tuesday, the House will begin consideration of HR 1, which provides continuing appropriations for the remainder of FY 11 (through September 30, 2011).
This column analyzes the House situation for FY 11; a separate column will preview the President’s FY 12 request. These are based on analysis I have done for the Alliance for a Stronger FDA, which is the leading voice for increased appropriations for FDA. I urge you to e-mail me at sgrossman@strengthenfda.org for more information about joining.
Read the rest of this entryFDA and the President’s FY 12 Budget Request: What to Watch For
February 13th, 2011Two upcoming events this week will set the tone for FDA appropriations for the next two years. On Monday, the President will release his request for FY 12 funding. On Tuesday, the House will begin consideration of HR 1, which provides for continuing appropriations for the remainder of FY 11 (through September 30, 2011).
This column previews the President’s FY 12 request; a separate column will analyze the House situation for FY 11. These are based on analysis I have done for the Alliance for a Stronger FDA, which is the leading voice for increased appropriations for FDA. I urge you to e-mail me at sgrossman@strengthenfda.org for more information about joining.
Read the rest of this entryNIH and Drug Development: Dr. Collins’ New Initiative
January 30th, 2011Dr. Francis Collins, director of the National Institutes of Health (NIH), wants to create a new National Center for Advancing Translational Sciences (NCATS) at NIH. The new Center would combine $700 million in existing NIH projects with, perhaps, an additional $300 million from new monies or other NIH programs. NCATS is intended as NIH’s “response” to the biopharmaceutical industry’s failure to produce more new drugs.
FDA Matters doesn’t see the sense of creating a public sector drug development company. Nothing suggests that government has either the requisite knowledge or experience to succeed. Yet, several people I respect are supportive of Dr. Collins’s initiative.
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