BATTLE OVER BIOTECH EXCLUSIVITY

On Sausage and Substance


The article below, excerpted from today's WSJ, links recent threads about extending patent exclusivity for biologics and the impact of constituencies on Congresspeople. It is not surprising, nor delinquent, that Sen. Kennedy is championing Amgen's et. al.'s cause. Senators and Reps always seek to advance the interests of their states, and industries within their states, for a range of reasons, and--in our system as it exists--it is expected that they do so. Thus what looks like "pork" from the perspective of Arizona may be tofu salad in New Jersey.

Still, given the system as it is, the question remains how much this strains the possibility of attaining rational national policy. It is, in a way, the reverse of the preemption issue philosophically--the extent to which balancing various interests and local constituencies can yield good policy or, in essence, a mush so compromised by compromise that there is, in effect, not much substance left.

That was my own initial assessment of the FDAAA. The effort to "keep everyone on board" led to throwing too much over the side. I would qualify some of my initial disapppointment, but my overall assessment is pretty much the same.

National healthcare policy is enormously more complicated. I understand that legislation is like "making sausage." On the other hand, every now and then there's some really great sausage.

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JULY 13, 2009
Blood Boils Over Bill To Protect Biotech Drugs

By ALICIA MUNDY
WASHINGTON -- The biotech industry is moving closer to a victory in Congress that would protect lucrative drugs from generic-drug competition for a lengthy period, though the issue continues to rile up lawmakers and consumer advocates.

The Senate Health, Education, Labor and Pensions Committee will be looking at a bill this week that would grant so-called biologic drugs -- those engineered from living cells -- made by companies like Amgen Inc. a total of 13½ years of intellectual-property protection, which is about twice the length of time proposed by the White House.

The proposal, introduced by the committee's chairman, Sen. Edward Kennedy (D.,Mass.), would be part of an ambitious health-care overhaul sought by President Barack Obama. It may prevail because it would help keep the pharmaceutical industry on board with the overhaul, said industry lobbyists and Senate staffers.

But the question of how long to protect brand-name biologics' intellectual property -- referred to as their 'exclusivity' -- has caused a rift in the health committee, which oversees the Food and Drug Administration, and in the overall Senate, industry representatives and Senate staff said.
It has also sparked an advertising battle between consumer groups, which want a shorter period of exclusivity for biologics, and the industry, which has said such an approach would hamper innovation........

[sound familiar?]