[CTC] Bill To Lower Biologics Exclusivity Period Characterized As Unrelated To TPP

[Arthur Stamoulis]

Bill To Lower Biologics Exclusivity Period Characterized As Unrelated To TPP
Inside US Trade
June 28, 2016
http://insidetrade.com/daily-news/bill-lower-biologics-exclusivity-period-characterized-unrelated-tpp <http://insidetrade.com/daily-news/bill-lower-biologics-exclusivity-period-characterized-unrelated-tpp> 
 
A bipartisan bill to lower the exclusivity period for biologic drugs in the United States from 12 to seven years is being characterized as an attempt to cut costs on life-saving medicines, with supporters and detractors of the legislation refuting any connection to the ongoing fight over the period of exclusivity for biologic drugs required by the Trans-Pacific Partnership.

Introduced on June 23 in the Senate by Finance Committee member Sherrod Brown (D-OH) and Sen. John McCain (R-AZ), and in the House by Rep. Jan Schakowsky (D-IL), the Price Relief, Innovation and Competition for Essential Drugs (PRICED) Act -- or H.R. 5573 and S. 3094 respectively -- hits at the center of an impasse between Senate Finance Committee Chairman Orrin Hatch (R-UT) and the Obama administration over TPP's biologics requirements.

Hatch has been adamant that TPP must require 12 years of exclusivity for biologics, as is currently required in the U.S. under the Affordable Care Act (ACA), but TPP requires either eight years of protection, or five years with additional measures.

In a statement supporting the legislation, Public Citizen's Access to Medicines Legal and Policy Director Burcu Kilic in a June 24 statement said the PRICED Act represents an opportunity to push back against TPP's biologics exclusivity requirements.

“This bill shows that the appropriate period of biologic exclusivity, if any, is still being actively debated both in the U.S. and internationally,” she said. “We should not buckle to pharma pressure to accept a long monopoly period under the TPP.”

An aide for Brown pointed out on June 27 that the senator had pushed to reduce the exclusivity period for biologics during the TPP negotiations as well as negotiations over the ACA, but did not comment on the talks between Hatch and the White House. The aide also said that Brown plans to work with McCain to advance the bill during the rest of the congressional session.

But Brown on June 28 told reporters after an event on TPP at the AFL-CIO that he doubted the PRICED Act would make its way to the president's desk this session. The legislation, he said, is not about making a statement regarding TPP but is aimed at combating rising drug prices by encouraging competition,

“This is the first time McCain has actually agreed to cosponsor [the bill]. We're not gonna pass it before now and then but it's a victory to get a prominent Republican senator to cosponsor. This is an issue that Republicans are very, very, very close to the biologic and the drug industry and anytime I can get some traction on this, I'm gonna move,” Brown said.

“I had really not thought of this connected to TPP until you asked, I really haven't,” Brown said. “It wasn't that at all. I've spoken out against the administration giving anything to Hatch on this.”

A Finance Committee aide, in response to a question about the legislation's potential impact on discussions between Hatch and the White House on biologics, told Inside U.S. Trade that Congress would be unlikely to move the bill. “Given that this proposal has been included in the President’s budget for the past eight years and has yet to be debated in earnest, it’s clear Congress lacks the desire to move such an initiative forward,” the aide said.

This sentiment was echoed by an industry source supportive of the 12-year protection period, who added that the current exclusivity period for biologics had extensive bipartisan support when it originally passed in the 2010 ACA.

The industry source also decoupled the PRICED Act from TPP by pointing out that the majority of cosponsors in the House are vehement free trade agreement opponents. Those cosponsors include Rosa DeLauro (D-CT), Marcy Kaptur (D-OH) and Lloyd Doggett (D-TX).

A Kaptur aide told Inside U.S. Trade that the congresswoman's support for the bill was based solely on the rising prices of drugs in the U.S. and did not have anything to do with TPP. The bill so far has not gained any additional Republican co-sponsors in either chamber.0

One industry source said McCain has not done much to support companies in favor of the 12-year protection period for biologics. McCain, however, voted in favor of granting President Obama fast-track authority last summer and has historically been a proponent of free trade agreements. McCain's office did not respond to inquires about the potential relationship between the PRICED Act and TPP.

The Generic Pharmaceutical Association and its Biosimilars Council also came out in favor of the PRICED Act, while the Biotechnology Industry Organization has stated its opposition to the bill. Neither industry group mentioned TPP in their respective statements.
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