Food and Drug Administration Reform Act of 2012

Floor Speech

BREAK IN TRANSCRIPT

Mr. TOWNS. 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.

BREAK IN TRANSCRIPT

Source