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Serious Wrinkle in a Biotech Bill

Those wrinkle-busting Botox injections can cost $500 a squirt, but if you were waiting for the price to come down when a generic version hits the market, well, get used to your frown lines.

That’s if a bill introduced late last week by Reps. Anna Eshoo (D-Calif.) and Joe Barton (R-Texas) makes it into law.

The measure, which would create a pathway for generic versions of biotech drugs, exempts pharmaceuticals that contain “select agents and toxins,” such as Botox’s botulinum toxin type A, mainly on the the grounds of national security, according to people on both sides of the issue.

Lobbyists for the generics industry, which opposes the bill, have taken to calling the exemption the “Botox carve-out.”

But while the carve-out would primarily target only Botox because it is currently on the market, in reality, these lobbyists say, the exemption could have far-reaching consequences for a portfolio of developing new treatments derived from poisonous fish, frogs, plants and other toxic agents.

“These things have a lot of potential for whole new pain relievers and other treatments,” said one lawyer for the generics industry who has studied the Eshoo-Barton bill, called the Pathway for Biosimilars Act. “And there’s no scientific justification for excluding these drugs from generic competition.”

The makers of Botox — Irvine, Calif.’s Allergan — lobbied for the exemption and said it’s a good idea, “appropriate public policy,” said the company’s in-house lobbyist, Bradford Gary, because it will ensure that toxins like botulinum won’t end up in the wrong hands.

It’s not about keeping Botox free of competition. “We’re going to have a major [name-brand] competitor, a U.K. company that’s pending approval,” Gary said.

As part of its lobbying effort, an Allergan lobbying firm, Jeffrey J. Kimbell & Associates, reached out to the Henry L. Stimson Center, a nonprofit, nonpartisan institution focused on international peace and security.

One House aide to a Member who sits on the Energy and Commerce Committee and a lobbyist working the issue both said another Allergan contract lobbyist, John McManus of the McManus Group, also has accompanied Stimson Center employees to Capitol Hill meetings.

Stimson senior associate Brian Finlay said he did a study on how terrorists and rogue states can pursue weapons of mass destruction through toxins studied or used for medical purposes.

“The same researcher who is working to develop a vaccine for ebola or plague could also use that same talent to weaponize one of those pathogens and use it as a biological weapon,” he said.

“Legitimate pharmaceutical companies are trying to produce products to make money, but they are bumping into this world of national security. So far as we know, Botox is the only one, but there are others in the pipeline,” Finlay said.

Finlay said that after being contacted by Kimbell & Associates, his organization handed out its report on Capitol Hill. He said he did not advocate for a carve-out for pharmaceuticals that contain toxic agents.

“We have no dog in this fight,” Finlay said. “We called for a tight chain of custody that would keep very close tabs on the point where they acquire the raw toxin to the point where it’s injected into the patient.”

A House Democratic staffer familiar with the drafting of the bill said that while the impact may be to keep generic Botox off the market, that “certainly wasn’t what we were intending to deal with,” and instead were keeping national security interests in mind.

A lobbyist for the generics industry said the national security argument doesn’t hold up. “They spin it as a national security issue — that botulism could be used in terrorist plots,” said this lobbyist. “I don’t know how in the hell they justify how generic botox is any more of a terrorist threat than brand-name Botox.”

For the first half of 2007, the most recently available, Allergan reported spending $200,000 on lobbying.

According to Senate public records, Allergan’s recent outside lobbyists have included, in addition to Kimbell and McManus, Arnold & Porter, McKenna Long & Aldridge, and King & Spalding. Allergan’s political action committee has donated to the bill’s sponsors, giving Eshoo and Barton each $5,000 in the 2008 election cycle, according to campaign finance records.

The Botox carve-out, though, is just one gripe the generics industry has about the overall bill, which the Biotechnology Industry Organization has hailed as one that protects patient safety and ensures continued innovation.

In a press statement, BIO’s president, former Rep. Jim Greenwood (R-Pa.), said “the bill recognizes the need to protect patient safety by calling for a set of studies demonstrating the safety and efficacy of the follow-on product, including clinical and immunogenicity studies.”

But Jake Hansen, senior vice president of government affairs for Barr Pharmaceuticals, which makes generic and name-brand products, said the bill is a victory for BIO because the pathway to a generic could take more than 14 years.

“This is really sad because right now BIO has a monopoly that will last forever because there isn’t a pathway to generics,” Hansen said. “Now they want to put into legislative language a pathway that will assure they never have generic competition.”

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