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Associated Press
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Expanding the use of low-cost generic pharmaceuticals would be near the top of the health care agendas of both Barack Obama and John McCain if elected in November, advisers for the presidential contenders said Thursday.

While the campaigns continue to trade barbs over who is best qualified to change Washington, the candidates' advisers praised generic drugs as a tool to lower drug costs.

"We know that expanding the use of generics and eliminating barriers to that goal must be a centerpoint of any health reform effort," said Dora Hughes, a health care adviser for Obama, the Democratic senator from Illinois.

McCain adviser Douglas Holtz-Eakin echoed that sentiment: "Controlling health care costs has to be the imperative of any effective health care reform."

Speaking at a conference for generic drug company executives, both campaigns pledged their support to help create a market for generic biotech drugs, a long-sought goal of industry leaders like Teva Pharmaceutical Industries and Mylan Inc.

Unlike traditional chemical drugs, biotech companies currently face no generic competition in the U.S. because the Food and Drug Administration lacks authority to approve copies of biotech medicines. Generally, biotech drugs are more complicated than regular drugs because they are made from living cells or bacteria.

The generic and biotech drug industries have spent millions of dollars in recent years lobbying Congress over how generic biotech drugs should be approved. Perhaps the greatest disagreement is over how long a biotech drug should be on the market before a generic drugmaker can challenge its patent. The Biotech Industry Organization has called for 14 years of market exclusivity, while its generic counterpart says drugs should get no more than five years of protection.

It appears biotech companies like Amgen Inc. and Genentech will face strong push-back no matter which candidate next occupies the White House.

"Senator McCain's instincts are to make the period as short as possible so that you can get products to market more quickly," Holtz-Eakin said of the Arizona Republican.

Obama also supports making the exclusivity period as short as possible for biotech drugs, Hughes said.

Lehman Brothers analyst Tony Clapsis this week wrote in a research note that Congress likely will pass legislation allowing generic biotech drugs by 2010. He expects the final compromise will give biotech drugs about 10 years on the market before facing competition.

Industry trends continue to favor generic drugmakers as more blockbuster drugs from the 1990s lose patent protection and begin competing with low-cost versions. Generic drugs already account for two-thirds of all prescriptions dispensed in the U.S., according to data presented Thursday by research firm IMS Health. That share will only increase as nearly $75 billion in drugs are expected to lose patent protection over the next four years.

The generic drug industry has witnessed a wave of mergers as companies try to streamline costs and snatch a larger share of the expanding global market.

In July, Israeli firm Teva cemented its status as the world's largest generics company with a $7.5 billion buyout of Montvale, N.J.-based Barr Pharmaceuticals. A month earlier Japanese pharmaceutical company Daiichi Sankyo Co. agreed to pay more than $4 billion for a controlling stake in Indian generic drugmaker Ranbaxy Laboratories.

The increasingly global nature of drug manufacturing has both the public and government concerned. The FDA this week barred Ranbaxy from importing more than 30 drugs, citing poor quality at two factories in India. Ranbaxy has retained former New York City mayor Rudy Guiliani and his consulting and investment firm to provide advice and review compliance issues.

Holtz-Eakin said McCain is troubled by the offshore movement of drug manufacturing and would rewrite the tax code to discourage it.

"The simplest way to make sure supply chains are safe is to make sure they begin and end in the U.S.," Holtz-Eakin said.

Hughes highlighted a separate industry practice that Obama would work to end: lucrative settlements known as "reverse payments," in which a brand-name company pays a generic manufacturer to delay the introduction of the generic drug.

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