***Insider Threats Neg Wave 1 – CFFP***
!!!!Counterplans!!!!
Reform the FDA CP’s
Funding and FDA Reform CP
Text: The United States federal government should double the budget for the United States Food and Drug Administration for 2015 and provide that funding level as a budget floor in fiscal years 2016-2020.
The counterplan restores FDA credibility by creating budget independence for the FDA – it doubles funding and eliminates the need for business and political influences on future budget levels.
Dr. Feder ‘9
(The FDA's Deadly Gamble with the Safety of Medical Devices,” pg online @ http://www.pogo.org/our-work/reports/2009/ph-fda-20090218.html#Recommendations //um-ef)
1. Budget and independence of the FDA. The FDA, more than most government agencies, needs markedly increased support by the administration and Congress. This includes increasing the FDA budget considerably and shielding it from excessive political and business influence. At least a doubling of the budget by 2012, as recommended by the authors of the FDA Science and Mission at Risk report, is needed. Strong leadership at the top is also essential. Until these reforms are implemented, correcting the worsening problems at the FDA will be very difficult.
2NC Solvency
Counterplan solves – lack of funding is the reason for the lack of Agency credibility
Modern Healthcare 13
(“FDA credibility hurting due to budget issues, commissioner says,” pg online @ http://www.modernhealthcare.com/article/20131105/NEWS/311059963/fda-credibility-hurting-due-to-budget-issues-commissioner-says //um-ef)
Federal budget cuts and budget uncertainty are hurting the credibility of the Food and Drug Administration, agency Commissioner Dr. Margaret Hamburg said Tuesday. At a conference hosted by Bloomberg Government, Hamburg said the stakeholders regulated by the FDA expect predictability and transparency in how the agency conducts its oversight. And that's been hard to deliver given the continuing federal budget wars. One problem has been the freeze on user fees paid by manufacturers who want their products approved for safety and efficacy. Because of the budget sequestration cuts, the FDA is set to lose $85 million in user fees in fiscal 2013, even though that money comes from regulated businesses, not from taxpayers. “You can't run agency as important as the FDA if you don't have predictability, if you don't know what budget you'll be given during the year, or if you don't know whether you can draw from certain resources or not,” she said. Increased responsibilities, such as regulating medical mobile apps, also have made the agency's work more challenging. She said the FDA has been “stretched thin for decades.”
User Fees CP
User fees make FDA accountable to Big Pharma rather than the public.
HOUSE SUBCOMMITTEE 07 (US Senator Chuck Grassley, R- Iowa- Chairman of the Senate Judiciary Committee; (TUESDAY, FEBRUARY 13, 2007; House Of Representatives, Subcommittee On Oversight And Investigations,Committee On Energy And Commerce; Washington, D.C., The Adequacy Of Fda To Assure The¶ Safety Of The Nation’s Drug Supply; http://www.gpo.gov/fdsys/pkg/CHRG-110hhrg35502/pdf/CHRG-110hhrg35502.pdf; 07/10/15) JG
Mr. STUPAK. Last month the FDA proposed an increase in annual¶ user fees paid to the agency by pharmaceutical companies to¶ improve drug safety oversight, the post-marketing surveillance we¶ speak of, to speed approval time for the new drugs and monitor direct¶ to consumer advertising. Do you think user fees give companies¶ too much influence over the FDA?¶ Senator GRASSLEY. Well, from that standpoint, it is kind of, since¶ money is fungible, I suppose it shouldn’t, but when you have got¶ an agency getting their money directly from the industry that they¶ are regulating, it is hard for the public and maybe for us, and it¶ causes us to be a little more suspicious here in the Congress, but¶ for the public that is unsophisticated about how Government¶ works, it is sure going to appear to them of undue influence. But¶ more importantly than just the user fees, I can make reference to¶ a lot of e-mails that we have had access to from within the FDA¶ that would say things along this line, and I don’t have a specific¶ reference. I could have my staff get you a specific reference, but¶ things that said well, if there is any question about this or that,¶ some specific drug they would mention, talk to us first or let us¶ have an opportunity to explain, et cetera. It is almost like the pharmaceutical¶ companies feel like they have a seat at the table and¶ maybe this fee business makes them feel that way. I don’t know¶ for sure. But the point is, there should only be one person across¶ the table from the FDA and that is John Q. Public, not members¶ of the pharmaceutical industry.¶ Mr. STUPAK. Senator, you went all the way to the Department¶ of Health and Human Services to talk to an agent regarding Ketek.¶ Has HHS finally given you access to that agent?¶ Senator GRASSLEY. Absolutely not and there is not reason to, but¶ their excuse is that there is a criminal investigation or there is an¶ investigation generally, see, an investigation generally. And I will¶ tell you how absurd this gets. Now, they referred to the fact that¶ the Department of Justice is advising them accordingly, see? So I¶ am sitting in Judiciary Committee in the United States Senate on¶ an entirely different issue and Senator Kennedy, with more seniority,¶ goes ahead of me and he says something to somebody from the¶ Department of Justice, I want to ask these line agents some questions.¶ Well, you can have access to these line agents.¶ Well, a light bulb goes off that Chuck Grassley can’t have access¶ to a line agent because somebody in the Justice Department told¶ HHS that I couldn’t talk to Agent West. So I talked to the Justice¶ Department about the situation right after Senator Kennedy gets¶ done and they said I could have access the same way Kennedy had¶ access, to other agents in some other department. I still don’t have¶ access to Agent West. So if the Justice Department is advising¶ VerDate 11-SEP-98 15:43 Jun 06, 2007 Jkt 000000 PO 00000 Frm 00024 Fmt 6633 Sfmt 6633 Q:\DOCS\110-5 SCOM1 PsN: SCOM1¶ 21¶ HHS that you can’t have access to Agent West but the Justice Department,¶ in a similar case of a line agent says Senator Kennedy¶ has, well, what is the policy of this administration on having access¶ to line agents? Is it one policy for Kennedy, a Democrat, and another¶ policy for Grassley, a Republican?
Ptix Net Benefit
And, politics is a net benefit – the cp is bipartisan and wont be controversial
AP 9
(“Is the FDA a broken agency?,” pg online @ http://www.today.com/id/29495269/43136851%20In%20the%20five%20years%20since%20the%20AP%20article%20was%20published,%20more%20disasters%20%20have%20occurred.#.VaiIwflVgSV //um-ef)
Congress has been pumping more money into the FDA the last couple of years. And the Obama administration seems willing to consider big changes, especially on food safety. The two leading candidates for FDA commissioner are physicians from outside the agency. One is Baltimore health commissioner Joshua Sharfstein, a pediatrician who has taken on the FDA over risks in children’s cough and cold drugs. The other is Margaret Hamburg, a bioterrorism expert who served in the Clinton administration and as New York’s health commissioner. “One area where we could see bipartisan cooperation might be the strengthening of the FDA,” said Dr. Paul Stolley, a former department head at the University of Maryland medical center who had a stint as a visiting scientist at the FDA. “I don’t think ideological differences should interfere.”
Other Reform CPs
Alt causes to FDA failure- CP solves better
HOUSE SUBCOMMITTEE 07 (US Senator Chuck Grassley, R- Iowa- Chairman of the Senate Judiciary Committee; (TUESDAY, FEBRUARY 13, 2007; HOUSE OF REPRESENTATIVES,
SUBCOMMITTEE ON OVERSIGHT AND INVESTIGATIONS,COMMITTEE ON ENERGY AND COMMERCE; Washington, D.C., THE ADEQUACY OF FDA TO ASSURE THE¶ SAFETY OF THE NATION’S DRUG SUPPLY; http://www.gpo.gov/fdsys/pkg/CHRG-110hhrg35502/pdf/CHRG-110hhrg35502.pdf; 07/10/15) JG
Even so, what I have learned about what happened with Ketek¶ troubles me. I have learned that FDA gave its advisory committee¶ questionable data on Ketek and did not tell them about problems¶ with that data. I sent a letter to the FDA in December regarding¶ my findings on this matter and I am still awaiting a response. The¶ FDA approved Ketek without much safety data from the U.S. The¶ agency relied almost exclusively on foreign post-marketing safety¶ data. And lastly, Ketek’s sponsor, in all likelihood, was aware of¶ the fact that it submitted some questionable data to the FDA regarding¶ its large safety study. The sponsor was informed of probVerDate¶ 11-SEP-98 15:43 Jun 06, 2007 Jkt 000000 PO 00000 Frm 00020 Fmt 6633 Sfmt 6633 Q:\DOCS\110-5 SCOM1 PsN: SCOM1¶ 17¶ lems with one of the study sites prior to the date of submission to¶ the FDA. However, according to the FDA reviewers, the sponsor¶ never raised these problems with the FDA. FDA learned about¶ them after his own investigators inspected the site.¶ During the last 3 years, I have also tried to work in a productive¶ way with the Commissioners and Acting Commissioners of the¶ FDA. It will take bold leadership to get on top of the FDA’s problems¶ and to turn the agency around. So far, lip service has been¶ fine; the reality has been a lot less.¶ Last month, Senator Chris Dodd and I introduced two reform¶ bills that we proposed in 2005 to get the safety, to fix the safety¶ shortcomings at FDA. Our first bill would elevate and empower the¶ office with the FDA that is responsible for monitoring FDA-approved¶ drugs after they are on the market. It would make the postmarket¶ safety function within the FDA independent, but within the¶ FDA, instead of under the thumb of the office and the center that¶ puts the drugs on the market in the first place and that is the way¶ it is today.¶ I want to point your attention to the Wall Street Journal in regard¶ to Chairman Dingell. It is reported that he is intrigued by the¶ idea of drug safety center within the FDA. I appreciate that view.¶ It doesn’t make any sense that the FDA officials who are supposed¶ to monitor the safety of a drug on the market serve only as consultants¶ to the FDA officials who approve the drug in the first place.¶ The officials who approve the drug would obviously be conflicted in¶ making a judgment that approval is no longer appropriate or was¶ a mistake in the first place. Kind of like having egg on your face.¶ A separate center for drug safety within the FDA is a vital¶ lynchpin when it comes to meaningful reform and improvement of¶ the agency’s post-marketing surveillance.¶ The second bill that Senator Dodd and I have introduced would¶ expand an existing public data base by mandating the registry of¶ all clinical trials and the results of those trials. This reform is key¶ to establishing greater transparency regarding clinical trials, the¶ good ones and the bad ones, and to hold drug makers and drug regulators¶ accountable and to give doctors all the information they can¶ to their patients. Both of these legislative initiatives would make¶ drug information used by doctors and patients more complete and¶ more accessible.¶ American consumers should not have to second guess the safety¶ of pills in their cabinet.
Only CP can solve FDA circumvention- plan doesn’t go far enough
HOUSE SUBCOMMITTEE 07 (US Senator Chuck Grassley, R- Iowa- Chairman of the Senate Judiciary Committee; (TUESDAY, FEBRUARY 13, 2007; HOUSE OF REPRESENTATIVES,
SUBCOMMITTEE ON OVERSIGHT AND INVESTIGATIONS,COMMITTEE ON ENERGY AND COMMERCE; Washington, D.C., THE ADEQUACY OF FDA TO ASSURE THE¶ SAFETY OF THE NATION’S DRUG SUPPLY; http://www.gpo.gov/fdsys/pkg/CHRG-110hhrg35502/pdf/CHRG-110hhrg35502.pdf; 07/10/15) JG
Mr. STUPAK. I understand. I want to respect your time. I am¶ done with my 10 minutes. Any comments, Mr. Green? Ms.¶ DeGette? Thank you. Thank you. Mr. Whitfield, please, for 10 minutes.¶ Mr. WHITFIELD. Thank you, Mr. Stupak, and I have one question¶ and then we will let the other Members on our side expend the 10¶ minutes.¶ Senator, we appreciate you being here. In your testimony, you¶ brought attention to one of the basic tenets of our Government and¶ that is the responsibility of oversight by the legislative branch and¶ I would just ask you a question because I think you have touched¶ on a significant issue, just the difficulty that you had in obtaining¶ information from a branch of the Government on the executive¶ side. Did you consider using a subpoena at any time to, not only¶ a subpoena, but holding them in contempt?¶ Senator GRASSLEY. In the Senate, you get to this place. We considered¶ that, yes. But you have to have a majority vote of the committee.¶ You have to have a majority vote of the Senate for that to¶ happen and so we did not decide to go that route because we¶ thought there were other routes we could go. Obviously, the other¶ routes have not been successful, either.¶ Mr. WHITFIELD. Well, we appreciate very much your bringing attention¶ to this issue and we look forward to working with you as¶ we try to address it and——¶ Senator GRASSLEY. Well, let me suggest to you, Chairman, or¶ Ranking Member Whitfield, that you can be very helpful. This double¶ standard in this administration, that a Democratic Senator,¶ supposedly not as friendly with the administration as I am, maybe¶ they don’t consider me friendly anymore, but the point is if Senator¶ Kennedy can get access to line agents why can’t Senator Grassley¶ get access to a line agent, when I have already had access to line¶ agents over the years? So some sort of new policy?¶ Mr.