[Congressional Record (Bound Edition), Volume 158 (2012), Part 6]
[House]
[Pages 8633-8634]
[From the U.S. Government Publishing Office, www.gpo.gov]




                HONORING THE ACHIEVEMENTS OF DR. AL MANN

  The SPEAKER pro tempore. The Chair recognizes the gentleman from 
California (Mr. Rohrabacher) for 5 minutes.
  Mr. ROHRABACHER. Mr. Speaker, there are many heroic people among us 
who have been involved in making our quality of life in America the 
best the world has ever seen and, at the same time, uplifting all of 
humankind. While we oftentimes focus our gratitude and our adoration on 
politicians and athletes and movie stars, we need to acknowledge the 
many innovators, inventors, and technology entrepreneurs who have 
played a significant role in overcoming the many challenges we humans 
face together, challenges to our health and limitations to our physical 
well-being.
  One of the most heroic of these special people is Dr. Al Mann. He 
flew in B-29s during World War II; and upon his return home, Al 
decided, instead of pursuing a career in the armaments industry, which 
could have been very lucrative, he would dedicate his life to building 
technologies that would improve the human condition.
  Among his many achievements are the following: a vast improvement 
over pacemaker technology, which then made that available to so many 
millions of people whose lives have been changed because of it and 
extended because of it.
  He also was involved in inventing, and it was his invention, a 
diabetic pump, a small mechanism that attaches to the body and allows 
patients to escape some of the worst ravages of diabetes.
  He perfected the fully implantable cochlear implant, an electronic 
device that provides patients, some of whom have never been able to 
hear, with the ability to hear sound almost as well as those of us who 
hear naturally.

[[Page 8634]]

  His latest invention and innovation would allow diabetics to receive 
their insulin through an inhaler rather than a syringe, a huge 
breakthrough that could be so meaningful to so many people who are 
suffering.
  His achievements ought to serve as an example of the power of 
innovation in our country. Just as incredible as his inventions 
themselves, Dr. Mann accomplished all of this with private funds. And 
instead of relying on government grants or contracts, Dr. Mann made the 
risky investments of his own and those of his investors; and then, with 
his labor and genius, when it paid off, he reaped the benefits, which 
he then plowed back into more research to help even more people 
eliminate even more suffering.
  Instead of receiving assistance from his government, Dr. Mann has, 
instead, run into bureaucratic obstacles time and again. As 
legislators, we have a responsibility to ensure that the Federal 
Government's actions, at the very least, do not thwart the heroic 
innovators such as Dr. Al Mann.
  For this reason, I submit for the Congressional Record a letter Al 
Mann recently penned. I encourage all of my colleagues to read what he 
has to say and to take seriously the disturbing observations with our 
current system, as well as his recommendations on how we can ensure 
that the incredible potential of human innovation can be and will be 
brought to play in improving the lives of the American people and 
people everywhere.

       Letter from Al Mann: The Senate has just passed a bill to 
     speed the availability of generic drugs. Hopefully that bill 
     will die in the House. I say that the problem is not the 
     pricing of drugs but the cost. What are needed are means for 
     effectively lowering the expense and time to get a new drug 
     approved. That would lower the costs and hopefully the 
     pricing of drugs, and that would certainly be a worthwhile 
     objective.
       I am shocked and disappointed at the lack of understanding 
     of this issue by the Congress. I certainly agree that we must 
     seek ways to lower health care expense. I say that to do so 
     we must focus on ways to LOWER the COST of providing health 
     care NOT just targeting the PRICE.
       There are multiple reasons for the price of drugs, but I 
     assert that the earlier generic drug law has actually led to 
     an INCREASE in the PRICING of drugs. It takes as long as 15 
     years--or even longer--and $1-$1.5 billion to gain regulatory 
     approval of a new drug. With only 20 years of exclusivity 
     before a generic drug is approved it should be obvious that 
     the price of a new drug must be very high just to recover the 
     development cost let alone a profit. Even the price of the 
     generic version of a drug is typically only moderately 
     discounted from the innovative drug rather than priced based 
     on the manufacturing cost.
       If you question the impact of the current generic drug law 
     just ask yourself how many $5 and $10 drugs there were before 
     that law. It only costs pennies to make a pill. However, only 
     by charging high prices can the high costs of pharma 
     development be recovered with any profit during the brief 
     period of patent protection remaining after regulatory 
     approval.
       Passing legislation to further ease and speed the 
     availability of generic drugs will not likely lower pricing; 
     if anything it would likely just reduce innovation of new 
     drugs. That slowing is already beginning; most of the major 
     pharma companies have already begun downsizing R&D. Surely 
     that is not in our interest when there are new advanced 
     technologies that could significantly improve and extend 
     life.
       We need to evaluate how we can speed and lower the cost of 
     bringing a new drug to market rather than counting on the 
     generics. There are various approaches that should be 
     explored. One approach might be to delay approval of a 
     generic to allow more time of exclusivity rather than to ease 
     the generic regulatory process. There was such a delay built 
     into the earlier bills, but that was certainly not adequate. 
     Unfortunately it will not be easy to reverse the pricing 
     practices of drugs--the companies and Wall Street have all 
     gotten used to the high prices.
       Of course the price of drugs is but a tiny part of the cost 
     of health care. We ought to be reexamining many aspects of 
     our health care system. We do need to reduce the price of 
     health care--including the cost and the price of drugs. 
     However, the challenge is not so simple as just approving 
     generic drugs more quickly.
       In fact the problem is not just the pricing; today many 
     potentially valuable improvements and even new breakthrough 
     drugs do not ever reach the market because of the regulatory 
     hurdles. This problem and the costs will certainly become far 
     greater as we move to more personalized medicine.
       The consequence of easing the creation of generics may even 
     worsen from what we see today; future breakthrough therapies 
     may simply not become available in the U.S.! I just heard 
     from a very credible person of a meeting of 12 advanced 
     pharma companies discussing how to deal with the current 
     regulatory challenges. I am told that 11 of those 12 
     companies are intending to launch their new products outside 
     the U.S. and just to ignore the U.S. patients. Heretofore 
     wealthy foreign patients came to the U.S. for superior 
     medical treatment. Perhaps that practice may be reversing.
       We want to protect our people from unsafe drugs. The 
     challenge is how to do so in a more cost effective and more 
     timely manner. I have suggested that we should redirect the 
     regulatory standards to concentrate on safety, to lower the 
     initial bar for efficacy to minimal requirements during a 
     reasonable safety trial and then to issue a ``provisional'' 
     approval. That provisional approval would be subject to a 
     thorough review of clinical benefits compared to risk AND 
     cost in something like a more rigorous REMS program.
       Our nation is in a crossroad on many fronts. In health care 
     the barriers are preventing our ability to topple diseases 
     such as cancer and Alzheimer's that so many of is will face. 
     Not only are we harming and even precipitating death of many 
     of our people but we are losing economic growth and the 
     engine for good paying jobs. Our government is the most 
     significant obstacle to medical progress today. We have new 
     tools from new science that could make such a difference if 
     only there were not the barriers to innovation that we see 
     today.
       I am 86 years old and surely my objective is not self 
     serving. For the past four decades I have been committed to 
     trying to find solutions to unmet and poorly met health care 
     needs. Yet I am so disgusted by the overly restrictive 
     process to medical innovation that has been created by our 
     government that I have begun to sell off most of my several 
     ventures. It is no longer worth the effort and the agony.
       I am sending this communication to all the Representatives 
     whose e-mail addresses I have. I would appreciate your 
     forwarding this to your other colleagues.
     Alfred E. Mann.

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