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Two Strategies for FDA Legislation in 2011

The current Congress will be remembered for its 15-month battle to enact health reform legislation. The FDA-related accomplishments have been less visible: an abbreviated approval pathway for bio-similar drugs included in the health reform law; and a food safety bill that may be enacted before Congress adjourns later this month.

In both cases, unanimity was never possible, but working majorities formed and prevailed. FDA Matters believes that any FDA-related legislation will falter in 2011 if it does not follow the strategy behind one or the other of these efforts. 

Bio-similars. The Democrats (Senator Kennedy and Representative Eshoo) leading the bi-partisan effort—and most of the Democratic rank and file who supported the legislation–come from high-tech, life sciences states and districts. Republicans joined the Democrats because of similar home-town support from life sciences companies and interest in promoting a pro-innovation, pro-economic development agenda.

The combination of Democrats with biotech interests and Republicans became a powerful force. It is also an approach that can be duplicated next year with a reasonable chance of success.

Indeed, another such effort is already underway regarding the medical device review process at FDA. Two weeks ago, 8 members of the Minnesota Congressional delegation sent Commissioner Hamburg a letter stating:

We support the FDA’s work to improve the process for the approval of safe and effective Class II medical devices but we must work to ensure that we continue to foster life-saving innovation and growth….and a larger goal of saving and improving patients’ lives….Changes that may jeopardize that goal should not be made unless there is clear evidence that the changes are necessary to address a public health problem.

The letter was signed by the state’s 2 Democratic Senators, 3 of its Republican House members and 3 of its Democratic House members. Elsewhere, the letter mentions that Minnesota has over 500 medical device companies that employ almost 35,000 residents at average pay-levels almost 50% higher than the state average.

Food Safety. As with bio-similars, there was a widespread consensus that food safety reform legislation was needed. The similarities between the two efforts end there.

Hill staff and key constituency groups held extensive discussions about needed changes. After lots of disagreements and some very tough negotiating, most Democrats and Republicans found enough common ground to move forward in the House.

The Senate also evolved a compromise version—somewhat different from the House, but with a similar breadth of support. Action stalled in the Senate because of cost issues and concerns about small food producers. But the core of support never disappeared.

When those concerns were addressed in the Senate, the other extraneous issues and disagreements fell away. Even the House appeared to have signaled that they would accept the Senate bill, rather than face further negotiation that might delay action until next Congress. Such deference has become increasingly uncommon in Congress.

I don’t want to minimize the difficulties in establishing and conducting negotiations on food safety. It may still fail. What made agreement possible was the willingness of constituency groups to work together, despite strongly held views that were often opposed. This approach can also work next year for other issues, as a broad-base of constituency groups lead Congress to a bi-partisan agreement on legislation.

The current Congress has not been known for its bi-partisanship. Some commentators think bi-partisanship may disappear altogether in the new Congress. Nonetheless, FDA is an area where getting the parties together is possible.

If consumer and patient groups, industry and associations and the Administration or Congress want to get anything done in 2011, they would do well to consider how the bio-similars and food safety strategies might apply to their cause.


The Minnesota delegation’s letter to Commissioner Hamburg about changes in the process of approving medical device. http://www.hpm.com/pdf/MNLegConcerns.pdf

Some relevant past columns:

All FDA Stakeholders Affected by Medical Device Reforms        October 31st, 2010
There are so many visible, contentious FDA issues right now….that reform of the medical device approval process has received only a fraction of the attention it deserves. Other centers at FDA and non-device stakeholders need to be watching more closely. FDA Matters is. Read the rest of this entry

FDA: An Honest Broker on the Slow Path to Bio-similars      October 24th, 2010
FDA Matters enthusiasm for bio-similars is a matter of public record. The market will build slowly, but 10 years from now the new law will be seen as ushering in a new age of biopharmaceutical product development. Read the rest of this entry

Fall Scorecard for Follow-on Biologics        September 11th, 2009
The creation of a regulatory pathway for follow-on biologics (FOB) has become a favorite topic of FDA Matters. The substance of the legislation is important and the politics are fascinating. It should get even better this fall. Read the rest of this entry

One Response to “Two Strategies for FDA Legislation in 2011”

  1. A useful history of the food safety legislation and the compromises that made it possible: http://www.congress.org/news/2010/12/08/lessons_from_food_safetys_success?all=1

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