Harkin Floor Statement on FDA User Fee Bill

WASHINGTON--Today, Senator Tom Harkin (D-IA), Chairman of the Senate Committee on Health, Education, Labor and Pensions, spoke on the floor of the Senate to urge his colleagues to invoke cloture on the Food and Drug Administration Safety and Innovation Act.

Below is the full text of Harkin's statement, as prepared for delivery:

"Mr. President, after many months of bipartisan negotiation, I have high hopes that the Senate will vote very shortly to invoke cloture on the House Message to accompany the Food and Drug Administration Safety and Innovation Act of 2012.  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, and of productive conversations with our colleagues in the House.  The House passed the FDA Safety and Innovation Act unanimously last week; now it’s our turn to do our part.

"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 (from 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 nascent 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.  And, more recently, from our colleagues in the House.  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 keeps 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 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 also reauthorizes and improves incentives for pediatric trials, creates incentives for the development of new antibiotics, and authorizes new drug and device provisions to help expedite the approval of important life-saving drugs and devices without sacrificing safety.

"In addition, the bill also helps address the national crisis of prescription drug shortages.  For the past several years, hospitals across the country and in my home state of Iowa have experienced an increasing number of shortages of life-sustaining prescription drugs.  These shortages directly threaten the public health by denying patients access to medications that are indispensable to their care.

"The FDA Safety and Innovation Act requires all manufacturers of certain drugs to notify FDA if they expect a manufacturing disruption that could lead to a shortage, because if FDA is aware of a potential shortage early, then the agency can work with manufacturers and providers to find other ways to get patients the drugs that they need. This bill also addresses drug shortages by explicitly allowing FDA to expedite drug establishment inspections and application reviews when needed to help prevent or mitigate a shortage. It also improves FDA’s internal processes by increasing in-house communication with drug shortage experts and enhancing record-keeping accountability. And it establishes an FDA drug shortage task force to develop a strategic plan to address drug shortages and to improve communication and outreach to stakeholders preparing for drug shortages.

"Another significant advance in the FDA Safety and Innovation Act is the much-needed modernization of the FDA’s authority to ensure the safety of drug products coming in to the U.S. from abroad.  It includes important provisions that could have helped prevent the tragic Heparin situation that led to American deaths a few years ago and that will help prevent future contamination. The FDA Safety and Innovation Act:

• Allows FDA to prioritize inspections of both domestic and foreign firms based on the risk they present to patient safety
• Requires importers to demonstrate that certain high risk drugs are safe and compliant before they can be admitted into the United States
• Requires manufacturer accountability and oversight of  the quality and compliance of their drug producers and suppliers
• Enhances penalties for adulterating and counterfeiting drugs
• Allows FDA to detain non-compliant drugs in U.S. commerce to prevent them from reaching patients
• Permits FDA to destroy certain illegal drugs at the border instead of releasing them back into commerce; and
• Clarifies FDA’s authority to address criminal conduct that occurs abroad and threatens the safety of U.S. consumers.

"An important point to remember about the importance of these safety provisions is that weaknesses in our pharmaceutical supply chain not only affect the health of American patients, they also affect the health of American businesses.  U.S. companies that source and manufacture drugs in this country should not be placed at a competitive disadvantage by foreign firms that operate with less oversight and sell substandard ingredients into this country at reduced prices. This bill will help ensure that businesses operate on a level playing field by holding foreign actors to the same high standards as those in the U.S.

"The last policy provision I’ll highlight is a mix of device and drug authorities 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.  In addition to the significant resources that will be devoted to rare-diseases under the prescription drug user fee agreement itself, the bill:

• expands the accelerated approval pathway to therapies for rare and very rare diseases, and instructs FDA to weigh the rarity of a disease as a factor in its approval process;
• directs resources to promising therapies for unmet medical needs, which will receive the new breakthrough designation;
• requires FDA to consult with outside experts on rare diseases;
• focuses on pediatric rare diseases by requiring a strategic plan regarding pediatric rare diseases and creating a pilot program to incentivize new therapies for pediatric rare diseases;
• helps make devices for rare diseases more available by modernizing provisions relating to custom devices and making it easier for companies to  make profits on devices for rare diseases, and
• reforms the conflict-of-interest rules for Advisory Committees to make it easier for FDA to fill panels, which will have particular impact regarding rare diseases, because those panels are often hard to fill.

"I am very proud of the advance this legislation will represent for patients with orphan and rare diseases.  

"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 $311 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.  

"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. 

"Let us come together, Democrats and Republicans alike, to pass this legislation, which is of such critical importance to the American people."

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