Novel Device Regulatory Relief Act of 2011

Mr. Speaker, the authorization of the FDA user fees will simply provide stability at FDA's new product review as companies submit new and innovative devices and drugs for their approval.

I'm especially proud that in this bill I had a piece of legislation called the Faster Access to Specialized Treatments--FAST--Act, which is H.R. 4132. It was included in the FDA Reform Act. This act modernizes the FDA accelerated approval pathways to reflect the 20 years of science developed since accelerated approval was first established in 1992. So think of that: since 1992, with this bill that I've included in our FDA bill, it will accelerate approval through the FDA. It will simply allow new drugs to get to market faster for people who are suffering from rare diseases. There are 30 million Americans suffering from one of over 7,000 rare diseases, but only 250 currently have any treatment. This act will save lives.

I would like to enter, Mr. Speaker, this letter of support for FAST signed by over 150 rare-disease groups into the Record.

I'm also glad that the FDA Reform Act includes the Expanding and Promoting Expertise in Review of Rare Treatments Act, EXPERRT Act, H.R. 4156. This will help FDA consult with medical experts when evaluating drugs dealing with rare disease such as cystic fibrosis. As the cofounder of the Cystic Fibrosis Caucus, I'm glad we're giving this tool to the FDA.

Mr. Speaker, I support passage of the FDA Reform Act.

March 23, 2012.

Hon. Cliff Stearns,

U.S. House of Representatives,

Washington, DC.

Hon. Edolphus Towns,

U.S. House of Representatives,

Washington, DC.

Dear Congressmen Stearns & Towns: On behalf of patients,

physicians, and other members of the health advocacy

community we are writing to express our support for H.R.

4132, the Faster Access to Specialized Treatments (FAST) Act.

This legislation will modernize and expand the FDA's

Accelerated Approval pathway to encompass a broader range of

diseases and leverage 21st century drug development tools and

strategies. This reform will speed the approval of much-

needed therapies and cures to patients who are facing serious

and life-threatening conditions, including Alzheimer's

disease, autoimmune diseases, multiple sclerosis, Parkinson's

disease, neuromuscular disease and hundreds of rare diseases

that remain untreated.

We commend you for championing legislation that maintains

the FDA's high standard for approval while at the same time

ensuring the Agency can help facilitate the development of

new and novel therapies to patients

in a more timely manner. In many cases our patients have no

available treatment for their diseases, or they are using a

therapy that is older and may not work as effectively and

safely. This is not acceptable. We believe that this

legislation will ensure patients receive the best, modern

treatment as soon as possible and we applaud your efforts on

their behalf.

Thank you for your leadership on this important bill and we

look forward to working with you as it moves forward.

Sincerely,

Abigail Alliance for Better Access to Developmental

Drugs; Advocacy for Patients with Chronic Illness,

Inc.; Affiliated American CSA Foundation; Alliance for

Aging Research; Alliance for Patient Access; American

Autoimmune Related Diseases Association; American Brain

Tumor Association; American Childhood Cancer

Organization; American College of Medical Genetics;

American Institute for Medical and Biological

Engineering; American Society of Clinical

Psychopharmacology; Batten Disease Support and Research

Association; Break Through Cancer Coalition;

Californians for Cures; Celiac Disease Center at

Columbia University; Celiac Sprue Association; Charcot-

Marie-Tooth Association (CMTA); Children's

Cardiomyopathy Foundation, Inc.; Chinese American

Association of Greater Chicago; Coalition Duchenne;

Coalition for Pulmonary Fibrosis; Colon Cancer

Alliance; Cooleys Anemia Foundation; Crohn's and

Colitis Foundation of America; Cryoglobulinemia

Vasculitis Organization; CureDuchenne; CurePSP;

Digestive Disease National Coalition; Erik Metzler

Foundation; EveryLife Foundation for Rare Diseases;

Fabry Support & Information Group; Georgia PKU Connect;

GIST Support International; Hadley Hope Fund; Hannah's

Hope Fund; Hayden's Batten Disease Foundation Inc.;

HealthHIV; Hope4Bridget Foundation; ICE Epilepsy

Alliance; I Have IIH; In Need of Diagnosis, Inc.

(INOD); Inspire; International Cancer Advocacy Network

(ICAN); Jacob's Cure, Inc.; Jain Foundation Inc.;

Jonah's Just Begun-Foundation to Cure Sanfilippo Inc.;

LAM Treatment Alliance; LGS Foundation; Liddy Shriver

Sarcoma Initiative; Little Miss Hannah Foundation; Lung

Cancer Alliance; Lupus Foundation of America;

Lymphangiomatosis & Gorham's Disease Alliance (LGDA);

Lymphatic Malformation Institute (LMI); Macular

Degeneration Support, Inc.; Madisons Foundation;

Midwest Asian Health Association (MAHA); MLD

Foundation; Mpdsupport.org--Myeloproliferative Disease

Support; Muscular Dystrophy Association; National

Family Caregivers Association; National MPS Society;

National MS Society; National Niemann-Pick Disease

Foundation, Inc.; National PKU Alliance; National Tay-

Sachs & Allied Diseases Association; National Venture

Capital Association; NBIA Disorders Association; New

Jersey Association for Biomedical Research; NKH

International Family Network; Noah's Hope--Batten Disease

Fund; Oxalosis and Hyperoxaluria Foundation; Pachyonychia

Congenita Project; Parkinson's Action Network; Parry-

Romberg Syndrome Resource, Inc.; Partnership for Cures;

Polycystic Kidney Disease Foundation; RARE Project;

Russell-Silver Syndrome Support; Scleroderma Research

Foundation; Sickle Cell Disease Association of America,

Inc.; Society for Women's Health Research; Solving Kids'

Cancer; Student Society for Stem Cell Research; Sudden

Arrhythmia Death Syndromes (SADS) Foundation; Taylor's

Tale; The Association for Frontotemporal Degeneration

(AFTD); The Children's Medical Research Foundation, Inc.;

The Erythromelalgia Association; The Focus Foundation; The

Manton Center for Orphan Disease Research, Children's

Hospital Boston; The Reflex Sympathetic Dystrophy Syndrome

Association (RSDSA); The Stop ALD Foundation; Tuberous

Sclerosis Alliance; Veterans Health Council; VHL Family

Alliance; Vietnam Veterans of America; ZERO--The Project

to End Prostate Cancer.

Mr. Speaker, I want to indicate my strong support of H.R. 5651, the Food and Drug Administration Reform Act of 2012, which we are addressing on the House floor today. This bipartisan legislation is not only good for the health of the American public; it is also a key component to restoring the health of our economy.

Nowhere will the impacts of this legislation be felt more than in Southern California and the San Diego region. According to BIOCOM, Southern California's life sciences cluster employs just over 97,000 in five sectors: biopharmaceuticals, industrial biotechnology and biofuels, life sciences trade, medical devices and diagnostics, and research and lab services. Medical devices and diagnostics is the region's largest life sciences sector, employing 33,871, followed by research and lab services with 31,878 jobs. These two sectors account for 68 percent of the total employment in the cluster, with over 65,000 jobs in the region. These innovative companies are on the forefront for discoveries from everything from Cancer therapies to the latest medical device that will prolong life.

The Food and Drug Administration Reform Act of 2012 will provide timely and necessary improvements to the user fee programs for drugs, medical devices, generics and biologics. Through this legislation, FDA will now be committed to meeting their performance goals for the review of life saving drugs--thus expediting these products to patients who need them, create an independent review entity to hold FDA accountable for the approval and clearance process for devices, as well as the creation of a new user fee program for generic drug and biologics approval all the while ensuring the safety of U.S. patients.

H.R. 5651 contains many provisions that will improve the lives of American patients and promote the competitiveness of the U.S. life science enterprise. However, there are two

provisions in this legislation that I am most proud of including. Included in the final House draft were two pieces of bipartisan legislation that I sponsored and worked with my colleagues on both sides of the aisle to get included. They are:

H.R. 3203, the Novel Device Regulatory Relief Act, coauthored with Representative Lois Capps (D-Santa Barbara) improves the FDA's third party review and inspection of medical devices by making the process more efficient, transparent, and beneficial to the life science industry seeking approval.

H.R. 5334, the Breakthroughs Therapy Act, coauthored with Representative Diana DeGette (D Denver) expedites the review of breakthrough drugs for patients with serious or life-threatening disease or a condition where preliminary clinical evidence shows an improvement over existing therapies.

As we move forward in reconciling our legislation with the Senate it is my hope that we can address another national crisis that was not included in the House bill--the need for a reliable track and trace system for pharmaceutical products. For years, Congress has attempted to craft legislation that would secure the distribution chain for pharmaceuticals. Either due to lack of consensus from industry and patient participants or poor timing, this was never accomplished. This lack of action has resulted in a patchwork of State laws which create opportunities for bad actors to shop for States with the lowest safety requirements in order to introduce unsafe products into the legitimate supply chain. This patchwork also creates regulatory uncertainty in the supply chain, which adds increased costs and burden to the health care system.

But this year is different. For the first time, we have seen industry stakeholders put aside differences and come to a consensus on a language that is supported by me and my friend Mr. Matheson that will create a national pedigree system which will replace a patchwork of State laws that are currently in place. While not a perfect solution, this legislation is a first step in creating a secure supply chain system that will protect the U.S. public from counterfeit drugs while preventing unwanted regulatory burden on American businesses. It is my goal to work with my colleagues to include track and trace language in the final legislation which will secure the drug supply chain and address the concerns of the large pharmaceutical distributors, secondary pharmaceutical distributors, local pharmacists, third party logistical providers and the large scale pharmacies.

In closing, I wish to thank Full Committee Chairman Fred Upton and Health Subcommittee Chairman Joe Pitts for their commitment to this issue. Without their guidance and hard work, this legislation would never have seen the light of day. I look forward to casting my vote in support of H.R. 5651 and urge my colleagues to do the same.

Mr. Speaker, the Food and Drug Administration Reform Act of 2012 is a product of nearly a year and a half of work in the Energy and Commerce Health Subcommittee. H.R. 5651 is the result of bipartisan negotiations. The bill passed out of the Health Subcommittee by a unanimous voice vote and passed out of the full committee 46 0.

I would especially like to thank Clay Alspach, Ryan Long, and Paul Edattel and the other staffers for their dedication and hard work in making this bill possible. I know they've put in a lot of hours; and because of that work, we have brought this bill to the floor in a timely manner.

The FDA Reform Act is critical to saving lives and sustaining a dynamic American industry. American companies are the leading developers of new medical devices and drugs to save and sustain life.

To ensure that products are both safe and effective, we've tasked the Food and Drug Administration with reviewing products before they make their way into the market. This is a big job. The device and drug industries are dynamic and innovative. Companies spend tens of millions of dollars and years of work to develop products.

The review stage is a critical time for any company. Inconsistent reviews mean that the true cost of developing a new product is hidden, making it difficult to properly prepare.

When we began considering this legislation last year, we heard from a number of individuals involved in the medical device industry about the increasing difficulty of working through the review process. American patients were waiting almost 4 years longer for new devices that had already been approved in Europe, and despite the slow review process, the safety outcomes were comparable.

The FDA Reform Act contains critical reforms to the Medical Device User Fee Act which will hold the FDA accountable and keep the reviews on schedule. Under the fourth version of the Prescription Drug User Fee Act, the median time of approval was 9

months. With the reauthorization, we set the goal of reducing the review time to 8 months. Currently, generic drugs have an average approval time of 32 months. Included in this legislation is a new user- fee program that should be able to gradually reduce review times to 10 months for most products. A separate user-fee program for biosimilars has the goal of 10-month approval times for most products. Finally, we also include language to help patients, doctors, and hospitals to deal with drug shortages.

Mr. Speaker, I am proud of the work we have done here. I would like especially to thank full committee Chairman Upton as well as Health Subcommittee Ranking Member Frank Pallone, full committee Ranking Member Henry Waxman, and their staffs for patiently working with us on the FDA Reform Act.

This is legislation to help save lives and create jobs, which are two goals that we can all agree on. It is a bipartisan effort, and I urge all Members to support the legislation.

Mr. Speaker, I yield 2 minutes to a gentleman who showed great leadership in the development of this legislation, in the negotiations, and has been a very integral part, the vice-chair of the Health Subcommittee, the gentleman from Texas, Dr. Burgess.

Mr. Speaker, at this time I am happy to yield 1\1/2\ minutes to the subcommittee chairman of O&I, the gentleman from Florida (Mr. Stearns).

Mr. Speaker, I yield 2 minutes to the gentleman from Pennsylvania (Mr. Murphy), a member of the Health Subcommittee, really the author of the sections on generic drug user fees and biosimilars in the bill.

Mr. Speaker, I yield 2 minutes to the gentleman from Georgia (Mr. Gingrey), another valued member of the Health Subcommittee, the author of the GAIN Act, the section dealing with antibiotics, and a valued participant in all these negotiations.

Mr. Speaker, I yield 2 minutes to the gentleman from Ohio (Mr. LaTourette).

Mr. Speaker, in conclusion, I want to again commend leadership on both sides of the aisle: Ranking Member Emeritus Mr. Dingell and Ranking Member Mr. Pallone and Mr. Waxman and Chairman Upton and staff of both sides. They have done a terrific job and spent countless hours. I especially want to mention Clay Alspach and Ryan Long on our side, as well as our personal staff. They have been absolutely terrific. Because of this, this legislation is going to save many lives. It's going to help the United States continue to be the world leader in the pharmaceutical and medical device industries and mean a lot to our economy as well.

I urge all Members to support this very important legislation, and I yield back the balance of my time.

Mr. Speaker, on that I demand the yeas and nays.

Mr. Speaker, I rise today in support of H.R. 5651, The FDA Reform Act of 2012. I would like to thank my colleagues for working with me and my staff on this important piece of legislation. As we move forward in the legislative process I would like to state the importance of maintaining the provision in the accelerated approval section that requests guidance from the FDA on how to implement reforms to the drug approval process enacted by Congress. During our discussion in subcommittee I submitted letters in support of this language from NORD, BIO, and fifty other patient groups. I hope that we maintain this guidance language as we continue to move through the legislative process.

I have only a few remaining concerns that I hope we can work through together before the bill is signed into law. One issue is regarding our drug supply chain security and the second is regarding medical device technologies which potentiate drugs.

For many years, creating a national standard on drug traceability, or pedigree, has eluded Congress. Realizing that the U.S. pharmaceutical supply chain has many safeguards in place and companies spend significant amounts of money to ensure the integrity of their products--criminals, thieves and other bad actors will stop at nothing to make profit off of the high value prescription drugs that are manufactured and sent throughout the distribution chain down to our pharmacies, and ultimately to patients and consumers. I support efforts to create consensus language on this issue that has the backing of stakeholders--from manufacturers, to distributors, wholesalers on down to pharmacists--all involved in various aspects of the U.S. supply chain.

We know that the other chamber was able to include ``placeholder'' language in its version of the FDA bill to ensure that conversations can continue to play out between FDA, supply chain stakeholders and Congressional stakeholders to come to a final consensus over the course of the coming weeks. Given the seriousness of this issue--to avoid additional injuries and potential deaths from counterfeit and adulterated product, and to avoid a patchwork of individual state laws to address an issue which clearly requires a federal solution--I would urge the FDA and all parties involved in these talks to find common ground so that we can include final supply chain integrity language into the final FDA user fee bill that is agreed upon between the two chambers. I would ask my colleagues on the committee to also support this request and signal their support as well.

My final concern is regarding medical device technologies. The Centers for Disease Control and Prevention (CDC) estimates that more than 70% of bacterial and fungal pathogens resist at least one of the drugs typically used to eradicate them. The CDC estimates that these infections are responsible for over 90,000 deaths annually and cost the U.S. an excess of $4 billion. These life-threatening infections also prolong hospital stays and create substantial additional costs in the fighting of these infections.

With such knowledge, the importance of innovative treatments such as patented laser technology that combat resistant organisms such as MRSA is pivotal. One section of this bill addresses the critical need to improve the pipeline of medical drugs identified as qualified infectious disease products (QIDPs). It has been brought to my attention that new peer-reviewed and patented laser technology is emerging that has the potential to eradicate drug resistant bacteria and fungus by potentiation of existing generic antimicrobial drugs while preserving human tissue. The standard definition of ``potentiation'' is when one drug enhances a second drug so that the combined effect is greater than the sum of the effects of each one alone.

With these innovative technologies, we can improve post-surgical and inpatient outcomes. Furthermore, these technologies have shown the potential to successfully treat over 2.7 million patients annually suffering from diabetic ulcers and lower limb and amputations. I hope the FDA will consider medical device technology which potentiate drugs as well QlDPs which have already been identified in this legislation in taking steps toward eradicating bacterial and fungal infections.

Mr. Speaker, this legislation has been the model of bipartisanship. I hope that we can continue our important work together to have these critical provisions affecting patients included in the final bill before it is signed into law.

Mr. Speaker, I yield myself such time as I may consume.

Today marks a very exceptional day in this body, one that deserves great praise. The bill before us, H.R. 5651, the FDA Reform Act of 2012, is the product of bipartisanship, collaboration, and compromise that I'm very proud of. The bill is a result of more than a year of negotiations between industry, FDA, and Congress.

In the Energy and Commerce Committee, we held a number of hearings on the critical issues within the bill, and earlier this month it passed unanimously in both subcommittee and full committee. The bill is slightly modified from the bill reported by committee, as it now includes a bipartisan provision which results in the bill reducing the deficit by $370 million over the next 10 years.

The FDA Reform Act will ensure that Americans have access to safe and effective new medicines and medical devices by reauthorizing the user- fee programs for prescription drugs and medical devices. It will reduce drug costs for consumers by speeding the approval of lower-cost generic drugs with the establishment of new user-fee programs for generic drugs and for lower-cost versions of biotech drugs.

The bill will also reform and revitalize many FDA programs to improve its regulatory scheme to facilitate a more efficient and predictable review process.

Mr. Speaker, the bill also makes permanent two complementary programs, the Best Pharmaceuticals for Children Act and the Pediatric Research Equity Act, which both help to foster the development and safe use of prescription drugs for children.

In addition, a significant improvement was made to the FDA's ability to police an ever-growing global drug supply chain to improve patient safety, and these provisions will give the FDA critical tools it needs to keep our medicine safer.

It also includes important provisions to help prevent and mitigate drug shortages by requiring that drugmakers notify the FDA in advance of any expected disruption in the supply of certain critical drugs, and for the FDA to inform health care providers of the potential drug shortage.

I want to thank Chairman Upton and Chairman Pitts, Ranking Member Waxman, Mr. Dingell, and my other colleagues on the committee for their leadership and dedication to this important piece of legislation, a special thanks to the staffs, in particular my staff person, Tiffany Guarascio, who's to my right. But on both sides of the aisle, the staff worked hard, and they should be very proud of what we've accomplished.

Reauthorizing and revitalizing the FDA user-fee system is a critical investment to our Nation's public health.

Mr. Speaker, I urge all Members of the House to vote ``aye.''

I reserve the balance of my time.

Mr. Speaker, I would like to yield 3 minutes to our chairman emeritus, Mr. Dingell, who has worked so hard and who has been so much a part of this legislation.

I yield 3 minutes to the gentlewoman from California (Mrs. Capps).

Mr. Speaker, I want to make a special thanks to another staff person for the committee, Rachel Sher, who is on my right here, as well. Thank you, Rachel.

I would now like to yield 3 minutes to the gentleman from Massachusetts (Mr. Markey).

Mr. Speaker, I yield 3 minutes to the gentleman from North Carolina (Mr. Butterfield).

Mr. Speaker, I am not expecting any more speakers, and I reserve the balance of my time.

Mr. Speaker, I just want to say in closing that I think it's a great example with this bill of what we can do, not only in the Energy and Commerce Committee but in general in this House, on a bipartisan basis when everyone works together for a common goal.

This is actually a very important piece of legislation. It's important for the pharmaceutical industry. It's important in terms of job creation. It's important in terms of innovation and also bringing low-cost drugs to the American people. Without the type of bipartisan cooperation we had, we would not have been able to get here with this time schedule, which is truly amazing. So I want to thank everyone. I would like to say that I hope that we can do similar good work in the remainder of this Congress, and I would urge my colleagues to vote ``aye.''

I yield back the balance of my time.