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FDA, Congress to Jointly Form Follow-on Biologics Proposal
[February 08, 2008]

FDA, Congress to Jointly Form Follow-on Biologics Proposal


(BioWorld Today Via Thomson Dialog NewsEdge) Washington Roundup

Rather than drafting a separate proposal about approval authority for follow-on biologics, the FDA has agreed to work with lawmakers on developing that legislation.

In the 2009 federal budget package revealed last week, the Bush administration said it would seek regulatory authority for the FDA to approve follow-on biologics, also called biosimilars or biogenerics, which would be financed through user fees. Currently, no such approval pathway exists for follow-on biologics. (See BioWorld Today, Feb. 6, 2008.)

The House and the Senate both introduced follow-on biologics legislation in 2007, with the Senate's bill moving the furthest by achieving passage by the Health, Education, Labor and Pensions Committee. Lawmakers are seeking to move the legislation forward this year.

Under a section in the FDA's 2009 budget document, called "Other Legislative Items," the administration said, "The Budget proposes a new authority for FDA to approve follow-on protein products through a new regulatory pathway that protects patient safety, promotes innovation, and includes a financing structure to cover the costs of this activity through user fees."


The administration said the "legislative proposal will include necessary provisions to ensure the safety and effectiveness of these biologic products for patients" and would contain "adequate intellectual property protections to preserve continued robust research into new and innovative life-saving medications."

At a hearing last week, Sen. Charles Schumer (D-N.Y.) praised the FDA for including a proposal for a new regulatory pathway for follow-on biologics in the fiscal year 2009 budget plan.

"I was really pleased to see that the administration included a proposal in the budget," he said. "It really would create great savings for both our government and our citizens."

Schumer said that he had met with FDA Commissioner Andrew von Eschenbach, who agreed that, instead of the administration submitting its own regulatory pathway proposal about follow-on biologics, the FDA "would sit down and try to do something jointly" with members of Congress.

Department of Health and Human Services Secretary Michael O. Leavitt, who appeared last Wednesday before the Finance Committee, agreed with a joint effort on the follow-on biologics pathway.

"It seems to me to be a better approach," Leavitt told the committee. "If we could reach agreement, we could get somewhere."

But FDA spokesman Christopher Kelly said that, despite Schumer's meeting with von Eschenbach and the senator's remarks at Wednesday's budget hearing, the agency had never intended to submit a separate follow-on biologics proposal to Congress. This despite the fact that the FDA had outlined in the Bush administration's budget document what such a proposal would contain, and that a high-ranking official had told reporters Feb. 4 that the agency was drafting a legislative proposal to send to the Hill.

"The language referenced in the budget document is an expression by FDA of our interest in moving this forward, not an actual proposal," Kelly said. "We will provide any needed assistance to Congress to accomplish this," he added.

Kelly would not comment on whether the agency had come under pressure by industry or lawmakers to soften the intent behind the FDA's language in the 2009 budget document. In addition, he maintained that regulators had not overstepped their legal bounds by including language about a legislative proposal in the administration's budget package.

Despite the FDA's new interpretation of the language in the 2009 budget document, which conflicts with what officials said earlier in the week and with Schumer's remarks at Wednesday's hearing, the language in the FDA budget plan will remain unchanged, Kelly said.

PTO Objects to Senate Patent Reform Bill

The Bush administration in a six-page "views" letter to Sen. Patrick J. Leahy, chairman of the Senate Judiciary Committee, outlined its objections to a patent reform bill awaiting Senate approval.

At issue is Section 4 of the bill, known as S. 1145, which addresses the right of the inventor to obtain damages.

"The requirements in Section 4 of the bill, as currently drafted, would likely lead to less than adequate compensation for many patent holders and could promote infringement," argued Nathaniel F. Wienecke, assistant secretary for legislative and intergovernmental affairs for the Department of Commerce.

"The administration does not believe it advisable to create a statutory directive to courts that requires them to rigidly apply, in all cases, only one of the several broadly accepted factors now evaluated by the courts," he wrote in the Bush administration's letter to Leahy.

Unless Section 4 is significantly revised, Wienecke noted, "the resulting harm to a reasonably well-functioning U.S. intellectual property system would outweigh all the bill's useful reforms."

While the administration supports legislation that would improve the patent system, the current version of S. 1145 "does not do that," insisted Jon Dudas, under secretary of commerce for intellectual property at the U.S. Patent and Trademark Office (PTO).

"In some ways, it undermines innovation, particularly in the damages provision," he asserted during a Feb. 5 media briefing.

"We want a bill, we just don't think what's there right now is the right bill," Dudas said.

The bill in its current form, he said, fails to strike the right balance for all innovators.

"At a time when the United States is promoting intellectual property rights and promoting innovation throughout the world, this is the time when we have to make sure we get it right in the United States," Dudas said.

The patent reform bill, which was passed by the House in a 220-175 vote in September, threatens the existence of biotech firms, universities and small inventors, Dudas contended.

Section 4 of S. 1145 limits the discretion of the federal courts in determining how damages are calculated to compensate a patent holder for patent infringement, Wienecke explained.

"The administration believes that such a dramatic change from current jurisprudence may have the unintended consequence of reducing the rewards of innovation and encouraging patent infringement," he said. "The U.S. patent system must preserve the incentive to innovate and continue to offer innovators the opportunity to be adequately compensated and recover their investments. Across all industries, most innovations are built on existing innovations. This progression of ideas has led to valuable inventions ranging from the light bulb to the airplane. The bill as written would undervalue such improvements."

Encouraging innovation within particular business models or technology sectors must not come at the expense of innovation in others, Wienecke told Leahy.

"Innovation can and will be encouraged in all industries by giving federal judges the flexibility to apply appropriate economic principles to the facts of each case, consistent with the business model or technology," he said.

Five Drug Classes Account for Most U.S. Spending

U.S. adults spend nearly $200 billion annually on prescription drugs, $36 billion of which is for medications to lower blood sugar, reduce cholesterol or help with other metabolic problems, the Agency for Healthcare Research and Quality reported.

In 2005, the most recent year for which data are available, Americans spent $33 billion on medications used to reduce high blood pressure or treat heart conditions, AHRQ said.

Central nervous system drugs, which include pain killers, sleep aid medications and drugs for attention-deficit/hyperactivity disorder cost the nation $26 billion, the agency said.

U.S. adults spent about $17 billion on drugs, such as antidepressants and antipsychotics, to treat mental conditions in 2005, while drugs used to treat gastrointestinal conditions, including antacids and laxatives, cost Americans $15 billion, AHRQ reported. n

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Copyright ? 2008 Thomson BioWorld, All Rights Reserved.

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