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In Floor Speech, Harkin Calls for Passage of Bipartisan FDA Safety and Innovation Act

WASHINGTON—Today, Senator Tom Harkin (D-IA), Chairman of the Senate Health, Education, Labor and Pensions Committee, spoke on the floor of the Senate to call for passage of the Food and Drug Administration Safety and Innovation Act (FDASIA), a bill which passed out of the HELP Committee with overwhelming bipartisan support.

Below is the full text of Harkin’s remarks, as prepared for delivery:

"Mr. President, after many months of bipartisan negotiation, I have high hopes that the Senate will proceed to consideration of the Food and Drug Administration Safety and Innovation Act of 2012.  And I am pleased to report that it is the product of excellent bipartisan collaboration on the Health, Education, Labor and Pensions Committee, which I chair. This bill reauthorizes important FDA user fee agreements, and systematically modernizes FDA’s medical product authority to help boost American innovation and ensure that patients have access to the therapies they need.

"The backbone of this legislation is the user fee agreements that FDA has negotiated with industry.  A sizeable part of FDA’s budget comes from user fees that industry agrees to pay to allow FDA to more quickly review product applications.  We need to authorize FDA to implement those agreements if we want to keep FDA running at full steam, which is critical to preserving jobs at both the agency and in industry, and to ensuring that FDA has the resources to get safe medical products to patients quickly.  I want to be clear, Mr. President: these agreements affect all of us by helping maintain and create jobs in our home states. For example, in my State of Iowa, these agreements will support our burgeoning bioscience sector, which saw employment grow by 4.5 percent between 2007 and 2008. Implementation of these agreements will continue to foster biomedical innovation and job growth in our states during these tough economic times.

"The bill before us reauthorizes the Prescription Drug User Fee Agreement – PDUFA, and the Medical Device User Fee Agreement – MDUFA, which will continue and improve the agency’s ability to speed market access to prescription drugs and medical devices while ensuring patient safety.

"The bill also authorizes the exciting new Generic Drug User Fee Agreement – GDUFA – which is expected to slash review times to a third of current levels (30 months to 10 months), drastically improving the speed with which generic products are made available to patients. This new generic user fee agreement will generate significant savings for patients and our health care system.  In the last decade alone, from 2001-2010, the use of generic drugs saved the U.S. health care system more than $931 billion. This agreement will ensure that we continue to see those savings and that patients have access to cheaper drugs when they need them.  This bill also authorizes the new Biosimilars User Fee Agreement – BsUFA – which will further spur innovation by shepherding the budding generic biologics industry as it matures. 

"These agreements are vital to FDA’s ability to do its job, to the medical products industry’s ability to survive these challenging economic times, and, most importantly, to the patients who are the primary beneficiaries of this long-standing and valuable collaboration between FDA and industry.  After months of negotiation, FDA and industry have crafted win-win agreements that they stand behind.  They have done their job.  Now it is time for us to do ours. 

Mr. President, it is absolutely imperative that we authorize these user fee agreements before they expire.  If we don’t, FDA will lose 60 percent of its drug center budget and 20 percent of its device center budget.  It will have to lay off nearly two thousand employees, which would grind the drug and device approval processes to an unacceptably slow place, with devastating consequences for patients whose health and lives depend on new medical treatments. 

"We cannot let that happen.  And that is why, for more than a year, I have worked closely with my colleague, Ranking Member of the HELP Committee, Senator Enzi, and other members of the HELP Committee.  Our aim has been to ensure that, in addition to the user fee agreements, the other key provisions in this legislation are also the product of consensus, bipartisan policy-making.  We have used bipartisan working groups and an open, transparent process to ensure that we had input from our Members and the stakeholder community at large throughout negotiations on the other titles in this bill. I think this is quite remarkable, Mr. President; we don’t see much of this in Congress these days.

"And let me assure you, this legislation has benefitted greatly from all of the diverse input—from Senators on both sides of the aisle, industry stakeholders,  consumer groups, and patient groups.  The FDA Safety and Innovation Act is the result of concerted efforts to define our common interests, and these efforts will directly benefit patients and the U.S. biomedical industry.

"As you can see from this chart, the bill modernizes FDA’s authority in several critical ways:

  • It authorizes key user fee agreements to ensure timely approval of medical products
  • It streamlines the device approval process while also enhancing patient protections
  • It modernizes FDA’s global drug supply chain authority
  • It spurs innovation and incentivizes drug development for life-threatening conditions
  • It reauthorizes and improves incentives for pediatric trials
  • It helps prevent and mitigate drug shortages; and
  • It increases FDA’s accountability and transparency

"As you can see, this bill addresses a broad array of critical issues that we face in today’s global economy. It is imperative that our regulatory system keep pace with and adapt to technological and scientific advances, and that patient protections remain strong in this era of dynamic change. 

"Keeping pace with the ever-changing biomedical landscape is precisely the aim of the FDA Safety and Innovation Act. This bill modernizes the Food and Drug Administration’s authority to ensure the safety of drug products coming in to the U.S. from abroad.  It injects greater transparency into the device approval process.  It bolsters FDA’s ability to help US manufacturers create innovative and safe devices, while also enhancing FDA’s ability to determine how devices perform in the real world and take appropriate measures to protect patients.  The bill addresses the critical problem of drug shortages, reauthorizes and improves incentives for pediatric trials, creates incentives for the development of new antibiotics, and authorizes new drug and device provisions that together can fairly be described as the most significant advance for patients of orphan and rare diseases since the Orphan Drug Act nearly 30 years ago.

"Not only does this bill support the biomedical industry and help patients get the medical products they need, it also reduces the deficit.  According to the nonpartisan Congressional Budget Office, Mr. President, this legislation would reduce the budget deficit by more than $363 million over the next decade. What we have here is not only good policy, but it is clearly fiscally responsible by contributing to deficit reduction in these tough economic times.

"Mr. President, as I have said, well over a year of diligent bipartisan work has gone into the legislation before us today, and I believe we have hit the sweet spot. Neither Democrats nor Republicans got everything they wanted in this bill. We sought out consensus measures.  And where we could not achieve consensus, we did not allow our differences to distract us from the critically important goal of producing a bill that everyone could support.  As a result, this is a true bipartisan bill, and it is broadly supported by the patient groups and industry.   I have received letters from over 100 groups, and even patients themselves, outlining their support for key provisions in this bill. To name just a few, I have received supporting letters from:

  • The PEW Charitable Trust
  • Consumers Union
  • Pharmaceutical Manufacturers Association
  • Generic Pharmaceutical Association
  • Biotechnology Industry Organization
  • American Academy of Pediatrics
  • Advanced Medical Technology Association
  • American Foundation for the Blind;

and many more.

"Mr. President, I would like to submit the full list of supporters for the record.

"The FDA Safety and Innovation Act authorizes the important FDA user fee agreements, and modernizes our regulatory system to ensure safety and foster innovation in the medical product industry. Our bipartisan work has produced an excellent bill. We cannot allow unrelated partisan disagreements or Presidential election-year politics to interfere, or to keep us from completing our job.

"Let me say it again; we must pass this vital legislation now. It is critically important to the agency, to the industry and, most importantly, to patients, that we get this done. 

"I urge my colleagues to join in the bipartisan spirit of cooperation that we have witnessed in the HELP Committee over the last year.  Let us come together, Democrats and Republicans alike, to pass this legislation, which is of such critical importance to the American people."