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A Salmon on Every Plate

Monday, October 17th, 2011

 

President Herbert Hoover supposedly promised Americans “a chicken in every pot” during his 1928 campaign. Chicken was an expensive delicacy then, so his message was about raising living standards, not ending hunger. Today, chicken is a low-cost source of protein and a mainstay of the American diet.

 

FDA Matters hopes that salmon (and other fish) will also become sources of low-cost protein over the next two decades. FDA is nearing the end of a long regulatory process, the outcome of which could be approval of a faster growing genetically-engineered Atlantic salmon. FDA must overcome opposition from environmental groups…and politicians and companies trying to protect the market for Pacific salmon.

 

The health benefits of fish are well-known. They are also a valuable source of dietary protein. However, our oceans are over-fished and aquaculture is now the source of almost 50% of the fish consumed worldwide. Expanding the availability of fish products meets a growing demand and is an important component of improved nutrition for Americans.

 

The proposal before FDA is for a genetically-engineered (GE) salmon that is biologically and chemically identical to the Atlantic salmon that is served in restaurants and at our own tables. The only difference is the inclusion of a Chinook salmon gene that provides the potential to grow Atlantic salmon to market size in about half the time.

 

Opponents have labeled the product as “Franken-fish.” It’s a catchy slogan that tries to vilify over a decade of scientific research and discredit several years of FDA review. Ultimately, the appeal is to emotion—that something dramatically new and different must automatically be dangerous. Decisions about new and different products are hard for FDA, as I wrote a few week weeks ago in a column entitled: “FDA and Things that Might Go Bump in the Night.”  

 

Approval of genetically-engineered animals will always require serious consideration of safety, environmental and ethical issues.  In this case—FDA’s first application for approval of a GE food product–the agency has been fortunate to have what might be considered a favorable factual context. No one questions the legitimate demands for more plentiful, high quality supplies of salmon. Further, the sponsor has agreed upon multiple redundant safeguards. For example, the GE salmon will be only sterile females and will be grown in inland fisheries with no access to either wild or farmed salmon stocks.

 

FDA has done its homework—digging deep into the relevant science and taking the time to consider all aspects of the issue. An agency decision is considered imminent and likely to be favorable….unless Congress tells it otherwise. A showdown may occur this week when the Senate considers the FY 12 appropriations bill for the Agriculture Department and FDA.

 

The House version already contains restrictive language forbidding the agency from spending any of its FY 12 monies to approve the application. However, according to some reports, only about a dozen Representatives were present when the amendment was adopted by voice vote during floor consideration.

 

In contrast, when the issue comes before the Senate this week, there will be debate and almost certainly a vote. Currently, about a dozen Senators are known to support the ban, with most of them from Alaska, California, Oregon and Washington, states that are the primary sources of Pacific salmon sold in the United States. 

 

Healthy, affordable high-protein food is always a desirable dietary option. At some time in the future, salmon could be as affordable as chicken if we allow the development of salmon that can be grown faster.  

 

The current fight is not just about “a salmon on every plate.” It is also about whether Congress will substitute its political judgments for FDA’s scientific decisionmaking. FDA Matters hopes that enough Senators will vote for FDA and against regional economic interests that want to protect existing sources of salmon production.

 

Steven

More information about salmon, aquaculture regulation of genetically-engineered foods and the current controversy can be found at: http://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/VeterinaryMedicineAdvisoryCommittee/ucm222635.htm and http://www.aquabounty.com/PressRoom/#l7

FDA and Things that Might Go Bump in the Night      September 18th, 2011

FDA’s everyday business requires balancing risk and benefit as these might apply to a particular medical product or a new food. Occasionally, FDA is faced with a much larger responsibility: judging a breakthrough technology that could bring great benefit or great sorrow to humankind. Who can confidently know in advance which it will be?

Still, FDA must decide. If they say “yes,” whole new industries and benefit may be created for patients and consumers. Or, the world and humankind may be subject to devastation. Today, the agency is faced with just such challenges in dealing with nanotechnology, genetically-engineered (GE) animals, and synthetic biology. Read the rest of this entry

Posted in FDA and Congress, FDA and Industry, FDA Appropriations, Food Issues | No Comments »

Can FDA Survive the Next Round of User Fee Legislation?

Sunday, September 25th, 2011

If FDA is to have sufficient money to operate in fiscal year 2013 (and thereafter), drug and device user fee legislation must pass Congress next Spring. That is the immovable object of the agency’s future. To pass legislation, Congress will need to plow through dozens of amendments touching every aspect of FDA and the industries it regulates. This is the irresistible force of Congress.

What happens when this irresistible force meets this immovable object? Something will need to give. FDA Matters hopes it will not be FDA’s ability to carry out its mission.   

The threat to FDA is created by two constraints imposed on the legislative process to reauthorize drug and medical device user fees.

First, the legislation needs to pass at least 90 days before the existing user fee programs expire on September 30, 2012 (i.e. by June 2012). During the last renewal cycle five years ago, the legislation wasn’t signed into law until September 21. As a result, FDA had to delay hiring new staff and the agency was compromised in its ability to implement the new law during the first year of the cycle.  

This time, there may be greater awareness by Congress of the problems created by delayed passage of the user fee legislation. However, this Congress has (thus far) a poor track record of reaching compromises on even simple matters and has demonstrated serious problems meeting deadlines.

Second, the user fee legislation is likely to be the only FDA-related legislation that “must pass” during this Congress (2011-2012). It provides Members of Congress a “one-time only” opportunity to advance their favorite issue or concern about FDA.

A partial list might include: drug re-importation; the exclusivity provisions of the new biosimilars law; approval of genetically-engineered salmon; regulation of dietary supplements; changes in the way that medical devices are regulated; and the use of Bisphenol A (BPA) in consumer products.  In addition, Congress now has some Members who might offer more fundamental amendments, such as revising FDA’s authority to review the efficacy of drug products.

The user fee reauthorization legislation will essentially have two parts. The core bill (“the inner bill”) will include renewals of drug and device user fees and adoption of new fees for generic drugs and other programs. In the best case, disagreements on these programs will be negotiable and compromises found.

Any additional amendments (“the outer bill”) are problematic. There may be some areas of agreement, such as new authority for drug import inspections, incentives for development of antibiotics, and provisions for addressing drug shortages.

However, as mentioned above, the outer bill will face a pent-up demand for resolution of controversial FDA-related issues. The House and Senate committees and leadership are going to have to deal with the onslaught—by allowing votes, negotiating compromises or adopting procedural barriers to prevent consideration of their colleagues’ amendments.

The risk for FDA is twofold. Even if “the inner bill” can be moved without problems, a lot of time will be required to deal with “the outer bill.” The clock will be ticking and June 2012 will arrive quickly. If Congress misses, FDA will be hurt. The longer it takes, the greater the damage.

Second, no one can predict which of the items proposed for “the outer bill” might be adopted. Some may make important and possibly undesirable changes in the agency’s mission and activities.   

Reauthorization of FDA’s user fee programs is essential, but difficulties are unavoidable and extend well beyond the fees themselves. FDA needs to be talking now with its many Congressional friends—not just about the details of the inevitable clash, but how to control the battle so it doesn’t get out of hand.

Steven

“Must-Pass Legislation” Key to FDA’s Future     December 12th, 2010

FDA Matters believes that the 2010 election will profoundly affect the FDA’s mission, priorities, funding, standards and work flow. Eighteen months from now, FDA’s leadership team will probably be the same, but the agency won’t be.

Identifying and understanding the likely changes to FDA requires examining the meaning of “must-pass legislation” and its escalating importance as a quarrelsome Congress turns into a divided Congress. At the moment, there is only one “must-pass” item on Congress’ FDA agenda: the next round of user fee renewals that will come before Congress in the Spring of 2012.  Read the rest of this entry

It’s Time to Change CDER Funding   September 17th, 2009

I did some crunching of FDA budget numbers for my column earlier this week on the Office of Regulatory Affairs (ORA). A by-product of my efforts was an analysis of how the Center for Drug Evaluation and Research (CDER) is funded. We often hear how dependent CDER is on user fees. The actual numbers are startling and deserve to be well-aired. Read the rest of this entry

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FDA’s Busy Summer of 2011

Tuesday, September 6th, 2011

Once upon a time, Washington slowed a little over the summer. Those days are long gone…and this was a particularly busy summer. Congress went down to the deadline on the debt limit/deficit reduction legislation, then left town for August. There was a continuous stream of FDA headlines in June, July and August.

FDA Matters focused on a number of the most pressing issues: post-market safety and surveillance; barriers and opportunities for increased drug discovery and approvals; the rising tide of imports; prospects for biosimilars and medical devices; FDA funding; and various crises facing the agency.

Here is a recap of the summer’s stories:

FAQ: How Biosimilars Will Transform the Marketplace      August 21st, 2011

Biosimilars will be a huge success–used by most prescribers at least some of the time. Much of the current negativity about the market for biosimilars is fed by a mismatch of expectations: the Biologics Price Competition and Innovation Act (BPCIA) is barely 18 months old, while the transformation of the marketplace will take a decade or longer. FDA Matters explores the likely evolution of the marketplace in a set of FAQs.  Read the rest of this entry

FDA Funding Prospects Altered by the Budget Control Act     August 14th, 2011

The Budget Control Act of 2011 (BCA) will have a heavy impact on FDA’s future. Under this new law, most discretionary spending programs will shrink—not merely cease to grow. Yet, FDA’s growing responsibilities and resource needs are not diminished because federal spending is being reduced. Our nation is less safe and less healthy if FDA cannot excel at its mission. Read the rest of this entry

People, Not Science, Make Decisions  August 8th, 2011

To FDA Matters, the people making the decisions at FDA are its strength. They are smart, conscientious and committed. Yet, when asked about bottlenecks at FDA, I have to admit that people slow the process down. There are good reasons why this is so. Read the rest of this entry

Medical Device Melodrama: A Great Story With a New Plot Twist  August 1st, 2011

Two years ago, FDA Matters urged FDA and Congress to review the 510(k) approval process for moderate-risk medical devices and predicted meaningful changes that would work for FDA, industry and consumers. FDA and industry have been proceeding along these lines (albeit with some tough negotiating and lots of rhetoric)…until the Institute of Medicine (IOM) declared that the current system is so flawed that a new regulatory framework is needed.  Read the rest of this entry

FDA, Reorganization and the Four Crises    July 24th, 2011

Dr. Hamburg’s reorganization plan addresses four crises that beset the agency: industry discontent with the medical product review process; public concern about import safety; implementation of the Food Safety Modernization Act; and Congressional concerns that the agency is inefficient in its use of resources. The new structure should drive better decisonmaking and greater productivity…. at a time when the agency is struggling to fulfill its growing mission and faces the potential for budget cuts.  Read the rest of this entry

Complexity, Uncertainty, Unpredictability: Not Necessarily Bars to FDA Approvals      July 17th, 2011

In most discussions of science and medicine, there is an implicit assumption that the human body is a complex biological machine. “The human body as a machine” is a metaphor, not a fact. Once we accept this, FDA Matters believes we can become liberated from unrealistic expectations about medical discovery and FDA’s role as a gatekeeper for new products that benefit patients. Read the rest of this entry

Should FDA Have an Independence Day?     July 4th, 2011

FDA Matters thinks that making FDA an independent agency will not make FDA more effective or more efficient. Although the idea is not truly harmful, proposing independent agency status is a seductive distraction from the tough job of improving FDA. Read the rest of this entry

Imports: FDA Issues a Cry for Help   June 26th, 2011

 No challenge to FDA’s mission looms larger than the rapid globalization of the world markets for food, drugs, medical devices and other FDA-regulated products. By way of making this point, the FDA released a special report, entitled “Pathway to Global Product Safety and Quality.”  FDA Matters read the report carefully and heard a cry for help, if not an actual primal scream. Read the rest of this entry

Post-Market Safety: Getting the Most Out of Inferences That Aren’t Proofs   June 21st, 2011

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.  Read the rest of this entry

Steven

 

 

Posted in Drug Approval and Access, FDA and Congress, FDA and Industry, FDA Appropriations, FDA Leadership, Follow-on Biologics, Food Issues | No Comments »

FDA Funding Prospects Altered by the Budget Control Act

Sunday, August 14th, 2011

The just-passed Budget Control Act of 2011 (BCA) will have a heavy impact on FDA’s future.  Under this new law, most discretionary spending programs will shrink—not merely cease to grow.  Yet, FDA’s growing responsibilities and resource needs are not diminished because federal spending is being reduced. Our nation is less safe and less healthy if FDA cannot excel at its mission

FDA Matters urges Congress and the President to see that increased funding of FDA is the only option.  Ultimately, the pressures created by the BCA will test the government’s commitment to FDA’s essential role in our society.  

Appropriations Caps and the Impact on FY 12.  The BCA limits discretionary federal spending for every fiscal year from 2012 through 2021. By capping annual appropriations growth, federal spending will be reduced by more than $900 million over 10 years.

For FY 12, the House and Senate appropriations committees cannot spend more than $1.043 trillion. Within this total, the ceiling for non-security programs (e.g. FDA, NIH, education, etc.) is slightly below the FY 11 appropriations level.

The ceiling is also substantially above the level the House has been using to mark up FY 12 bills. This is particularly encouraging because the House-passed Ag/FDA appropriations bill would cut FDA by $285 million below FY 11 (-11.5%) and $572 million below the President’s FY 12 budget request (-21%).

Senate staffs are currently preparing FY 12 appropriations bills using the aggregate spending levels in the BCA. Subcommittee and then full committee mark-ups are expected to start in early to mid-September.  Advocates, notably the Alliance for a Stronger FDA and its members, have been encouraging the Senate to put more money into FDA. The goal is to provide the agency with an increase in its FY 12 appropriation, not merely undo the cuts proposed in the House bill.

FY 13 Appropriations and Beyond.  A second part of the BCA requires a further reduction of the federal deficit by $1.2 trillion over the next 10 years. This can be achieved by any combination of changes in entitlements, revenues and appropriations.  

To pull together this deficit reduction plan, a so-called “super committee” has been appointed. It is composed of 12 members—3 each from the majority and minority parties in the House and the Senate. The group’s work must be completed by November 23, 2011. Any resulting bill will not be amendable and must pass Congress by December 23, 2011. If no legislation passes or the President fails to sign it, then across-the-board cuts (“a sequester”) will occur during  fiscal year 2013, which starts on October 1, 2012.

The general consensus in Washington is that the super committee appointees are too divided ideologically to pull together the needed deficit package. Democrats will only accept entitlement changes if there are new tax revenues. Republicans are pledged to oppose any tax increase.

Predictions of failure may be premature because the super committee will be under intense public and political pressure to find a compromise. In addition, sequester cuts would fall heavily on defense programs that most of Congress supports.

FDA is vulnerable in the “super committee/sequestration” process in two ways.

  • If the super committee produces a plan, it may include further cuts in discretionary spending. There is no guarantee that Congress would allocate those cuts in a way that would protect FDA and other essential programs.
  • If the super committee does not produce a plan, then the sequester would go into effect in FY 13.  If the entire 10-year $1.2 trillion in savings must be found through sequestration, then FDA is likely to sustain an across-the-board reduction in FY 13 of at least 8% to 10%.

Conclusion. Over the last five years, FDA has been one of few discretionary programs to receive substantial funding increases. This reflected both Congressional and Executive Branch recognition that the agency was dramatically underfunded for its growing responsibilities in an increasingly complex world. FDA still needs more resources, even though the downward budgetary pressures have become significantly greater.

Steven

Imports: FDA Issues a Cry for Help          June 26th, 2011

No challenge to FDA’s mission looms larger than the rapid globalization of the world markets for food, drugs, medical devices and other FDA-regulated products. By way of making this point, on June 20, the FDA released a special report, entitled “Pathway to Global Product Safety and Quality.” FDA Matters read the report carefully and heard a cry for help, if not an actual primal scream. Read the rest of this entry

 

 

FDA “Exceptionalism” at the Funding Crossroads       May 2nd, 2011

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 entry

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FDA Appropriations: Good News for FY 11…A Struggle in FY 12

Wednesday, May 25th, 2011

 

FDA survived the FY 11 (current year) appropriations process with an increase of about $107 million. The agency was the only account in the agriculture appropriations bill that received more money in FY 11 than it did in FY 10. Very few domestic discretionary programs received increases.

 

FY 12 will be harder. All the “easy” cuts have been made. In the House, the appropriations subcommittees were given very small allocations for programs under their jurisdiction. As a result, the initial House position for FY 12 has included cuts to FDA.

 

On May 24, 2011, the House Agriculture Appropriations Subcommittee marked up the FY 2012 appropriations bill. The chairman’s mark—adopted by the subcommittee–proposed cutting the FDA’s budget authority (BA) appropriations by $285 million for Fiscal Year 2012 (starts October 1, 2011). This represents an 11.5% cut from the recently passed FY11 Continuing Resolution, which funds the government until September 30, 2011.

 

This cut represents a significant decrease and would put FDA’s appropriation below its FY10 number and more than $500 million below what the President requested for the agency in FY12.

 

FDA

FY 10  Final

FY11  Final  CR

FY 12 House Appropr. S/C  May 24, 2011

FY 12 President’s

Request—Feb.14, 2011

Budget Authority appropriations

 (no user fees)

$ 2.361 billion

  $2.457 billion

   includes -0.2% across the board cut of $5 million

$ 2.172 billion

$285M below FY 11

$2.744 billion

 

 

The House appropriation committee’s press release states that the overall cut in the agriculture appropriations bill is 13.4%. FDA’s 11.5% cut is slightly better, on average, than other agencies within the agriculture appropriations jurisdiction. Every area of FDA activity would sustain cutbacks under the House subcommittee bill. (For exact breakdown by Centers, go to: http://fdaalliance.files.wordpress.com/2009/11/fy-12-fda-approps-house-sc-by-center-5-24-11.pdf)

 

FDA will have about $288 million more in user fee income in FY 12, about the same amount by which budget authority appropriations have been cut. However, user fees are limited in scope and only pay for specific activities. The Alliance for a Stronger FDA does not consider an increase in user fees as justification–or an offset–for decreases in BA appropriations. I agree.

The Alliance for a Stronger FDA’s press release on the House subcommittee mark-up is at: http://strengthenfda.org/media/media-release-may-24-2011/. The Alliance is the only multi-stakeholder group working to increase FDA’s appropriations. Its 180 members represent consumer, patient and health professions’ groups, as well as companies, associations and individuals.

The Alliance will be working hard to restore funding to FDA when the full House Appropriations Committee marks up the subcommittee bill on May 31 or June 1, 2011. While the FDA’s case is strong, the pool of available monies is so small that there probably won’t be any progress at the full committee mark-up.

It is generally assumed the Senate will be more favorable to domestic discretionary programs. However, the situation is unclear.  The Senate is at an impasse with regard to a FY 12 Budget Resolution…and the appropriations subcommittees have not yet been given allocations on how much they can spend.

The Senate may start to move on appropriations bills in June or early July. More likely there will be no action until the House and Senate reach a deal on raising the debt ceiling, which must be done by August 2.

Advocates for more funding for FDA must continue to stress that the agency provides essential services. There is no fallback—no other agency to do FDA’s work–if there are insufficient monies.

Steven

For purposes of disclosure: I am one of the founders and serve as Deputy Executive Director of the Alliance for a Stronger FDA. For more information about the Alliance, go to www.StrengthenFDA.org or write to me at sgrossman@StrengthenFDA.org.

Posted in FDA and Congress, FDA Appropriations | No Comments »

FDA “Exceptionalism” at the Funding Crossroads

Monday, May 2nd, 2011

The 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. (more…)

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FDA and Its Regulated Industries: A Cornerstone of America’s Economic Future

Monday, March 7th, 2011

 

On 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.

(more…)

Posted in FDA and Congress, FDA and Industry, FDA Appropriations, Insight on FDA-regulated Industries | No Comments »

FDA Is Fighting on Two Fronts

Sunday, February 27th, 2011

FDA 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. (more…)

Posted in Drug Approval and Access, FDA and Congress, FDA and Industry, FDA Appropriations, Planning for FDA's Future | No Comments »

FDA and Congress: FY 11 Deficit Reduction Could Cut Deep

Sunday, February 13th, 2011

Two 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. (more…)

Posted in FDA and Congress, FDA Appropriations | No Comments »

FDA and the President’s FY 12 Budget Request: What to Watch For

Sunday, February 13th, 2011

Two 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 advocacy voice for increased appropriations for FDA. I urge you to e-mail me at sgrossman@strengthenfda.org for more information about joining. (more…)

Posted in FDA and Congress, FDA Appropriations | No Comments »

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