White House's 2013 Budget Includes FDA Increases - Pharmaceutical Technology

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White House's 2013 Budget Includes FDA Increases


ePT--the Electronic Newsletter of Pharmaceutical Technology

President Barack Obama released his budget proposal for fiscal year 2013. Included in the proposed budget is a $654-million increase in FDA funding, for a total FDA budget request of $4.49 billion.

The proposed budget also includes $1.97 billion in user fees, including $583 million in proposed new user fees. The budget request includes “inflationary increases for FDA user fee programs, as authorized by law.”

“The resources in this budget will allow FDA to perform its fundamental public health responsibilities in new and more efficient ways. Our budget also supports industry efforts to innovate and bring new products to market that will benefit American patients and consumers and strengthen our economy,” states FDA Commissioner Margaret A. Hamburg, in the FDA portion of the proposed budget.

Included in the proposed FDA budget is an additional $363 million earmarked for projects that protect patients, including addressing and detecting risks from products manufactured in China. “The budget contains new resources to increase FDA’s capacity to detect and address risks in products and ingredients manufactured in China before they result in harm to Americans,” states Hamburg.

The proposed FY 2013 budget sustains the current level of staffing and activities for the Medical Countermeasures Initiative, which is designed to meet national security and public health requirements for medical countermeasures (MCM) readiness. FDA will continue to partner with industry and academia to shorten MCM development timelines and improve success rates.

Health and Human Services Deputy Secretary Bill Corr, in a press statement, states the proposed Health and Human Services budget “continues to support President Obama’s historic push to stamp out waste, fraud, and abuse in our health care system…and our budget helps reduce the deficit by $366 billion over 10 years, almost all of which comes from reforms to Medicare and Medicaid.”

PhRMA expressed concerns about the President’s proposed budget and the changes to Medicare in a prepared statement, “Medicare Part D is working well for seniors. Due to competition, costs continue to be far below initial projections. We should not disrupt this successful program.”

PhRMA also responded to the budget’s handling of data protection, biosimilars, and patents. “We are also troubled by the President’s proposal to reduce data protection for innovative biologic medicines, which is critically important to the development of cutting-edge medicines so needed by patients… The biosimilars provision of the health care reform law—the only provision in the law to garner strong bipartisan support—achieves an essential balance. It provides appropriate incentives to support future medical advances. It supports high-value jobs that are critical to our nation’s economic recovery. And, it provides savings by creating the first pathway for federal regulators to approve biosimilars.”

“Similarly, patent settlements are a vital aspect of a patent owner’s ability to protect intellectual property. Restricting such settlements, which already are subject to review by the Federal Trade Commission and the Department of Justice, could discourage pro-consumer settlements, which often bring generics to market years before patent expiration. Without settlements, costly litigation could keep these generics from being available to patients for years.”

The President’s Health and Human Services FY 2013 budget can be downloaded from the HHS website.

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