Video of Entire Floor Debate


The following text is only of the remarks made by Congressman Michael C. Burgess, M.D. on the FDA Reauthorization

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

Before he leaves, I want to thank Chairman Dingell for his willingness to work with the minority side on this. We had a lot of give-and-take, both at the staff level and certainly at the subcommittee level and the full committee level, and for that I am grateful.

I think this is a good piece of legislation, and I think it was improved by the work of the staff, both on the majority and the minority side, and I think it was improved by the committee process as we worked this bill through committee.

I am pleased to support H.R. 2900, and this bill, of course, will improve the drug and medical device safety approval by the FDA.

Over the past several weeks, members of the Energy and Commerce Committee, both Republican and Democrat, have come together to hammer out a bill that will ensure that the American people can rely on the decisions made by the Food and Drug Administration, that their drugs are safe, and that regulatory requirements don't overly infringe on innovation or sound clinical practice of medicine.

H.R. 2900 will achieve several goals, such as providing additional resources to the Food and Drug Administration to improve premarket drug and device approval, create new postmarket surveillance authorities, enhance clinical trial transparency and data mining, and ensure the adequacy of pediatric studies for drugs and devices.

I would like to thank, again, Chairman Dingell and Chairman PALLONE for working with our Republican staff to improve this legislation before we convened the markup, and of course during the process of the markup, again, both at the subcommittee and at the full committee level.

I'm pleased that we were able to modify the Direct to Consumer Advertising provision to protect this bill from a constitutional challenge, Mr. Speaker, and in a manner relying on the existing Food and Drug Administration regulatory standards.

In regard to pediatric exclusivity, the committee was able to find a workable standard as opposed to the original proposal that would have required the Food and Drug Administration accountants to post a lot of overtime in their jobs.

I'm also pleased with regard to one of my concerns about how the new postmarket surveillance regime would impact the independent practice of medicine. I'm pleased that Mr. Waxman, Mr. Pallone and DINGELL and their staffs worked with me to improve the language relating to the restrictions on distribution and use pursuant to elements of a drug's risk evaluation and mitigation strategy. Certainly, Mr. Speaker, it was not the intent, or I did not feel it was the intent of our legislation to be circumventing clinical judgment of trained and experienced practitioners. The original language threatened clinical decision making that is both lawful and based on scientific evidence and sound medical opinion, but I'm pleased that it has been tempered by the concerns that I raised to the above-mentioned gentlemen.

One issue that I hope we will continue to work on as this bill moves toward conference committee relates to the provision on conflicts of interest.

The Food and Drug Administration advisory panel serves a vital science function when it comes to the approval of drugs and devices.

I believe that we should strive to weed out any conflicts of interest for those that serve on these panels.

But in reality, Mr. Speaker, that is easier said than done. The standard established in this bill, limiting panels to one waiver for a conflict of interest, could severely impair the Food and Drug Administration's advisory panel process, especially for panels convened to review drugs or devices targeted at very small patient populations, such as those with very rare diseases. For drugs or devices that would fall into these categories, it can be extremely difficult to find sound scientific experts. This irrational standard will only make it harder to perform that function. Moving forward, I hope we can find and strike the acceptable balance.

It has already been shown that our collaboration on this endeavor has produced better legislation. I hope we continue that as the process moves forward.

Mr. Speaker, I reserve the balance of my time.

BREAK FOR OTHER SPEAKERS

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

Number one, my understanding is as we took this bill through the subcommittee and committee that we accepted legislative language on an amendment that would provide for a reverse trigger so that if the gentleman and other appropriators want to provide more money for the evaluation of new drugs and devices, the actual contribution from the user fees will decrease. After all, it was a Democratic Congress in 1992 that began the first Prescription Drug User Fee Act, and the reason for that legislation was because it simply took too long to get drugs and devices through the regulatory maze. And as a consequence, practicing physicians such as myself were denied access to life-saving medications for their patients. So the Democrats in the early 1990s improved the process by adding the prescription drug user fees, but we would all be happy with the appropriators if they would step up to the plate and appropriate the correct amount of money.

Additionally, let me just point out that consumer groups and patient groups actually are going to be involved in the negotiations for the next prescription drug user fee authorization. That is language that was brought to us, I don't remember by which side, but it was an amendment that was accepted by the full committee. So, Mr. Speaker, although there are concerns expressed by the gentleman who just spoke, the reality is many of those things were actually addressed through the committee and subcommittee process.

I will speak a little further on the conflicts issue as I do my closing remarks on this bill, but Mr. Waxman so eloquently spoke about how unfortunate it was we stripped out an Institute of Medicine recommendation in his previous remarks. The reality is that the Institute of Medicine recommended that waivers be available for up to 40 percent of FDA panels. Those are the individuals who are the exerts and who understand what these compounds can and cannot do.

Mr. Speaker, I recognized throughout the committee process that I had a responsibility as the only member on the committee on either side who had ever picked up a pen and written a prescription for a patient, who had ever sat down face to face with a patient and talked about benefits and potential risks from medications, and who had ever talked to a patient about the cost of their medication.

I think this legislation was well crafted and well worked up between both sides as we went through the committee process.

Mr. Speaker, I reserve the balance of my time.

BREAK FOR OTHER SPEAKERS

Mr. BURGESS. Mr. Speaker, I yield myself the balance of my time.

Again, Mr. Speaker, I want to point out, Mr. Waxman in his remarks discussed the Institute of Medicine study, and in fact, when we talked about the issue that's still the unresolved issue of the conflict-of-interest waivers, the Institute of Medicine itself recommended that the Food and Drug Administration advisory panels, those panels that are convened to advise the Food and Drug Administration on the acceptance or rejection of new drugs and new devices, that that panel could be comprised of up to 40 percent of individuals for whom a conflict-of-interest waiver was obtained.

The current legislation has language in it that will restrict that waiver to one such individual, and as we've already heard from the other side, even that one conflict waiver is too much for some people to tolerate. But the reality, if the FDA is allowed to issue only one waiver per panel meeting, they will find themselves seeking the guidance of fellows that have just passed their boards and are beginning their practice of medicine. The drafters of the code of Federal regulations did not intend that only the most recent graduates of a fellowship program or residency program be considered the so-called expert.

At present, medical societies find restrictions on the FDA panel nominees increasingly difficult due to a number of criteria that must be met in addition to considerations for the conflicts of interest.

The Food and Drug Administration panels must have geographic, ethnic and gender diversity. We've already heard discussion from the other side of how they're concerned about aggravating ethnic disparities. Here's another place where we could perhaps reverse that trend.

For clinical representation, panel members on those Food and Drug Administration advisory panels, panel members should be practicing physicians and, in fact, should have practiced for many years. They should have accumulated a body of experience. They should have knowledge of the conduct of clinical trials. They should have knowledge of statistics.

They should have intricate knowledge of the specific anatomy if they're on a device panel. They may need to know about the biomechanical forces imposed on the anatomy if a device is implanted or the cellular biology to determine wear and tear on the devices and knowledge of the American Society for Testing and Materials or international standards organizations. Members may also need to know about the packaging and the effects of radiation on many of the device components.

For some panels, such as on March 29 of this year, the Cellular Tissue and Gene Therapies Advisory Committee meeting to provide guidance to the Food and Drug Administration on biological license applications, such as the medicine that might be used for treatment of men with asymptomatic metastatic hormone refractory prostate cancer; these panels must have a specific knowledge base that far exceeds that of a practicing physician.

And indeed, I heard from other individuals where the universe of patients may be quite small for patients who have a certain type of brain malignancy. The universe of patients may be only 1,000 or 1,500.

The people that develop the drugs are of necessity going to be people who have been employed by those industries that were developing the drugs. Why exclude them from the panel? Why craft a law where the only people in the room are, by law, going to be people who have no knowledge of the intricacy of the specific disease being treated or no knowledge of the surgical procedures required to implant those medical devices? Why restrict ourselves in that way?

We just heard eloquent testimony from the gentlewoman from Arizona talking about the devices and those medications and treatments that are just over the horizon to us right now that we can't imagine, we can't envision. Why restrict those Food and Drug Administration advisory panels to one conflict-of-interest waiver?

Mr. Speaker, I will submit being in public service can be expensive, it can be time-consuming, and it can be embarrassing. Why make it harder for these individuals to participate in these panels? Frankly, I do not understand that. I hope we will continue to work on that process as we get to the conference activity on this bill. I'm looking forward to those discussions.

But in reality, the bill that is before us today is, in fact, a good bill. The committee staff on both sides did great work as far as getting language that would be acceptable to both sides, and we were not an easy audience to please on many occasions through the debate on that bill.

But Mr. Speaker, I do rise in support of the bill. I do think it is worthy of the House's consideration and passage.

Mr. Speaker, I yield back the balance of my time.