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house Bill H.R. 2430

Should the FDA’s Drug User Fees on Drug Manufacturers be Reauthorized?

Argument in favor

This bipartisan reauthorization bill will ensure the FDA has the resources it needs through continued access to user fees assessed on manufacturers of drugs, medical devices, and biosimilar products.

Sherry's Opinion
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08/03/2017
They created the epidemic and got rich from it so they should be accountable and help with treatment. I lost my son to opiate overdose. My son was prescribed OxyContin long term after back surgery. I voiced my concern about addiction and the Dr said, "we worry about pain now and addiction later" but later there was no help. I spent over $100,000 on all types of treatment because in those days there was no insurance coverage for addiction. Yes those who profited so bigly should take part of that profit and provide treatment.
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Ticktock's Opinion
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08/10/2017
The user fees should be continued but the FDA should provide more oversight and more thorough testing of pharmaceuticals.
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Pamela 's Opinion
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08/04/2017
Thank you to Senators Duckworth and Durbin for your "yes" votes. I am proud to have you represent me!
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Argument opposed

The FDA doesn’t need the funding it generates by its user fee programs that collects fees from manufacturers of drugs, medical devices, and biosimilar products.

Deirdre 's Opinion
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08/03/2017
Stop taxing the people who need either medication or devices to live. Tax the corporations who make billions off of the sick.
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Diana's Opinion
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08/03/2017
No. This will only be passed on to patients. They need to find ways to decrease the price of drugs, not increase them.
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Chase's Opinion
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08/03/2017
If it provides a funding mechanism for the FDAs then let's get rid of it. The FDA is the largest barrier to entry in the pharmaceutical industry which substantially raises prices and provides near monopolistic protections for pharmaceutical companies. We already have doctors providing the "consumer protection" element so that's not even a necessary function. End the FDA altogether if we can!
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What is House Bill H.R. 2430?

This bill would reauthorize the Food and Drug Administration’s (FDA) authority to collect user fees from the makers of prescription brand drugs, medical devices, generic drugs and biosimilars, and several other FDA programs through 2022. Under current law, user fee agreements — which provide a substantial amount of the FDA’s funding — are set to expire on September 30, 2017.

Drug Fees

This section of the bill would reauthorize the FDA’s authority to collect and credit fees related to drugs. It would be able to collect fees at a higher level and restructure the fees to reduce administrative burdens. The fee structure would being divided evenly divided between facility fees, application fees, and product fees to being 20 percent application fees and 80 percent program fees for approved products. The base fee amount would rise from over $718 million to more than $878 million.

The existing reauthorization process would be maintained by this bill, under which the Dept. of Health and Human Services (HHS) would provide recommendations to Congress by January 15, 2022 after holding public hearings. The FDA would be authorized to collect fees until October 1, 2022 and would need to submit performance and financial reports to Congress on January 31, 2023.

Medical Device Fees

This section would reauthorize the FDA’s authority to collect and credit fees relating to medical devices. It would allow for new authority to collect fees for de novo classification requests. The target base fee amounts would be updated, with FY2017 set at over $130 million, FY2018 increased to about $183 million, and more than $213 million in FY2022. The FDA would be authorized to collect fees until October 1, 2022 and would need to submit performance and financial reports to Congress on January 31, 2023.

Generic Drug Fees

This section would reauthorize the FDA’s authority to collect and credit fees relating to generic drugs. Fees for prior approval supplements would be eliminated, and a generic drug applicant program fee would be established that requires manufacturers with more approved applications to pay a greater share of the fee. One-third of the total revenue would come from generic drug application fees, 20 percent will come from generic drug facility fees, seven percent will come from active pharmaceutical ingredient facility fees, and 35 percent will come from the new generic drug applicant program fee.

The base fee amount would rise from $299 million in FY2017 to $493 million in FY2018. The FDA would be authorized to collect fees until October 1, 2022 and would need to submit performance and financial reports to Congress on January 31, 2023.

Biosimilar Product Fees

This section would reauthorize the FDA to collect and credit fees for biosimilar products. A fee structure would established that has an initial fee during clinical trials, an annual development for new biosimilars, and a program fee for sponsors of approved biosimilars. The base fee amount would increase from $20 million to $45 million. The FDA would be authorized to collect fees until October 1, 2022 and would need to submit performance and financial reports to Congress on January 31, 2023.

Impact

Manufacturers of drugs, medical devices, and biosimilar products; and the FDA.

Cost of House Bill H.R. 2430

The CBO estimates that enacting this bill would reduce the aggregate deficit by $72 million over the 2018-2027 period.

More Information

In-DepthSponsoring Rep. Greg Walden (R-OR) introduced this bill to reauthorize the FDA’s critical drug user fee programs:

“This bipartisan work has produced a big win for patients. FDARA will help bring lower-cost generic drug alternatives and biosimilars to market faster — increasing competition and lowering drug costs — and it will streamline the process for reviewing and approving new treatments and cures for patients, ultimately delivering new and innovative therapies, drugs, and devices to patients more quickly.”

Lead cosponsor Rep. Frank Pallone (D-NJ) added:

“The swift reauthorization of these user fee agreements is critical to making sure FDA has the resources and personnel it needs to ensure timely review and approval of safe and effective medical treatments. These carefully negotiated agreements encourage innovation, improve our regulatory review process, and provide certainty to both patients and industry. I look forward to working with my colleagues to move this legislation through Congress and to the President's desk.”

This passed the House Energy and Commerce Committee on a 54-0 vote, and has the support of three bipartisan cosponsors — two Democrats and one Republican. The bill passed the House on a voice vote.


Media:

Summary by Eric Revell

(Photo Credit: U.S. Air Force - Senior Airman Kristin High / Public Domain)

AKA

FDA Reauthorization Act of 2017

Official Title

To amend the Federal Food, Drug, and Cosmetic Act to revise and extend the user-fee programs for prescription drugs, medical devices, generic drugs, and biosimilar biological products, and for other purposes.

bill Progress


  • EnactedAugust 18th, 2017
    The President signed this bill into law
  • The senate Passed August 3rd, 2017
    Roll Call Vote 94 Yea / 1 Nay
  • The house Passed July 12th, 2017
    Passed by Voice Vote
      house Committees
      Committee on Energy and Commerce
      Health
    IntroducedMay 16th, 2017

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    They created the epidemic and got rich from it so they should be accountable and help with treatment. I lost my son to opiate overdose. My son was prescribed OxyContin long term after back surgery. I voiced my concern about addiction and the Dr said, "we worry about pain now and addiction later" but later there was no help. I spent over $100,000 on all types of treatment because in those days there was no insurance coverage for addiction. Yes those who profited so bigly should take part of that profit and provide treatment.
    Like (20)
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    Stop taxing the people who need either medication or devices to live. Tax the corporations who make billions off of the sick.
    Like (47)
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    No. This will only be passed on to patients. They need to find ways to decrease the price of drugs, not increase them.
    Like (33)
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    Soon we have to confront the fact that our prescription drug costs are still the highest in the world. The question is WHY?
    Like (32)
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    If it provides a funding mechanism for the FDAs then let's get rid of it. The FDA is the largest barrier to entry in the pharmaceutical industry which substantially raises prices and provides near monopolistic protections for pharmaceutical companies. We already have doctors providing the "consumer protection" element so that's not even a necessary function. End the FDA altogether if we can!
    Like (19)
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    The user fees should be continued but the FDA should provide more oversight and more thorough testing of pharmaceuticals.
    Like (7)
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    The FDA doesn’t need the funding it generates by its user fee programs that collects fees from manufacturers of drugs, medical devices, and biosimilar products. In the end any additional costs are passed onto the consumer and drug prices in the US are already out of control. No more user fees and start finding ways to cut consumer costs for the medications and medical appliances they need.
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    Patient costs are ridiculous now
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    No, the costs will be passed on to the end user. Drug prices are already too high.
    Like (4)
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    Thank you to Senators Duckworth and Durbin for your "yes" votes. I am proud to have you represent me!
    Like (4)
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    Another example of government interference causing problems that people somehow blame on the free market.
    Like (3)
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    The FDA is a Necessity to keep the drugs brought out by companies BUT WHY ARE THESE COMPANIES FUNDING THE FDA??? That should be a governmental responsibility. Take some of the 60% of the US budget used for the bloated cost of military armaments and that ridiculous wall and use it to fund the FDA.
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    Drug companies, have been raking us over the coals four years, America pays more money for drugs than any other country, it takes the FDA years before they will allow drugs into our country that have been proved to be good in other countries. It Is extremely difficult for seniors we have the donut hole when you are on Social Security, to be able to get the drugs that you need, I'll week at our generic if we can get that which basically is being made in other countries, generic drugs you don't know how much of the ingredient that you need is in there it has arrange, they are filled with fillers you may be allergic to one of those fillers does the FDA care NO can we get a medication does not generic NO we are turn down by your insurance company which way to Bible don't have a clue. I am sick and tired of our government, when Obama talk about Obamacare one of the things he promised West to close the donut hole for seniors, I have friends that could not get their medication because they couldn't afford it pharmaceuticals in America they rule they can do whatever they want charge whatever they want and who's with them our government democrats republicans as far as I'm concerned that's a one party system I have no faith if either party
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    These fees would be ultimately, and exude to keep raising drug prices, and a potential for yet another emollients based conflict of interest in our government. Regulate prices, treat them as a utility, and hold them accountable via corporate taxes. Do. It create a back door to kickbacks.
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    Did anyone catch the fact that contamination issues at manufacturing plants are solved by the company having a plan of action and giving their word that it will be handled. No longer is reinspection required. They also decreased the inspection schedule. Great. Not only does this place us all in even more danger but it's a major conflict of interest, causing the FDA to have a vested interest in their decisions. It's so clear that people are actually missing it. Unbelievable.
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    Stop taking money from the people
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    Victoria needs to be deported from our country.
    Like (1)
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    When has the CBO ever been RIGHT !!!!! they manipulated Obama care and are B. S > !!!!
    Like (1)
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    This should have been voted down, but it wasn't because Congressmen need more money, and ANY chance they get to get more money, they will take it.
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    It makes sense to have drug manufacturers make contributions to the public. Although I would feel better having more information about what the FDA does with the funds.
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