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Prescription Drug User Fee Human activity
Citations

Long title	An Act to amend the Federal Food, Drug, and Cosmetic Act to authorize human drug application, prescription drug establishment, and prescription drug product fees and for other purposes.
Acronyms (colloquial)	PDUFA, DSA
Nicknames	Dietary Supplement Human activity of 1992
Enacted past	the 102nd United states Congress
Constructive	October 29, 1992
Public law	102-571
Statutes at Large	106 Stat. 4491
Codified
Acts amended	Federal Food, Drug and Cosmetic Act
Titles amended	21 U.s.C.: Food and Drugs
U.S.C. sections amended	21 United states of americaC. ch. 9, subch. VII § 379g et seq.
Legislative history
Introduced in the House every bit H.R. 6181 past John Dingell (D–MI) on October half-dozen, 1992 Committee consideration past House Energy and Commerce Passed the House on October 6, 1992 (passed without objection) Passed the Senate on October seven, 1992 (passed voice vote) Signed into police force past President George H. W. Bush on October 29, 1992

The Prescription Drug User Fee Act (PDUFA) was a law passed by the U.s. Congress in 1992 which allowed the Food and Drug Assistants (FDA) to collect fees from drug manufacturers to fund the new drug approval process. The Act provided that the FDA was entitled to collect a substantial application fee from drug manufacturers at the time a New Drug Application (NDA) or Biologics License Application (BLA) was submitted, with those funds designated for use only in Center for Drug Evaluation and Research (CDER) or Center for Biologics Evaluation and Research (CBER) drug approval activities. In order to continue collecting such fees, the FDA is required to run across sure operation benchmarks, primarily related to the speed of certain activities within the NDA review process.

History [edit]

The move towards imposing user fees to pay for the regulatory review of new medicines was the result of dissatisfaction among consumers, industry, and the FDA. All three groups felt that drug approvals were taking far too long. Pharmaceutical companies had to wait to begin to compensate the costs of inquiry and development. The FDA estimated that a filibuster of ane calendar month in a review's completion cost its sponsor $10 million. The FDA argued that it needed boosted staff to end its dorsum-log of drugs awaiting approval for market. The FDA had non received sufficient appropriations from Congress to hire them. For decades the FDA had asked for permission to implement user fees and the pharmaceutical manufacture more often than not opposed them, fearing that the funds would not be used to speed drug review. The 1992 constabulary became possible when the FDA and industry agreed on setting target completion times for reviews and the hope these fees would supplement federal appropriations instead of replacing them.^[1]

AIDS epidemic [edit]

The length of the drug approving process barbarous nether severe scrutiny during the early years of the AIDS epidemic. In the belatedly 1980s, Act-UP and other HIV activist organizations accused the FDA of unnecessarily delaying the approval of medications to fight HIV and opportunistic infections, and staged large protests, such as a confrontational Oct xi, 1988, activeness at the FDA headquarters which resulted in roughly 180 arrests.^[2] In August 1990, Louis Lasagna, then chairman of a presidential advisory panel on drug approval, estimated that thousands of lives were lost each year due to delays in approval and marketing of drugs for cancer and AIDS.^[3] Partly in response to these criticisms, the FDA introduced expedited approval of drugs for life-threatening diseases and expanded pre-approval access to drugs for patients with limited treatment options.^[4] All of the initial drugs approved for the treatment of HIV/AIDS were approved through accelerated blessing mechanisms. For instance, a "handling IND" was issued for the first HIV drug, AZT, in 1985, and approval was granted ii years afterward, in 1987.^[v]

AIDS activists, desperate for new treatments, were outraged at the toll of those showtime drugs and the slow stride of drug development. These activists bombarded the authorities and drug companies with complaints and public protests. The activists won a major victory in 1989, when Burroughs Wellcome implemented a 20% toll cutting on AZT, then still the only treatment for HIV. Even later on this toll concession, the 12-pill-per-day AZT regimen cost patients $6,400 a yr. AIDS activists expressed their acrimony by trashing booths at medical conventions and continuing song public protests. Gradually, drug companies established relationships with AIDS activists and the two sides came together to improve clinical trials. By August 1991, relations had warmed upwards so much that Deed-Upwardly founder Larry Kramer wrote Bristol-Myers Squibb primary Richard Gelb a letter of congratulations on the imminent approval of Videx. AIDS groups fought for the reauthorization of the Orphan Drug Human action and the passage of the Prescription Drug User Fee Act in 1992.^[6]

PDUFA I [edit]

The Prescription Drug User Fee Human action (PDUFA) was first enacted in 1992. PDUFA gives the Food and Drug Administration (FDA) a revenue source, fees paid past pharmaceutical companies seeking the blessing of new drugs, to supplement but not supplant straight appropriations from Congress. PDUFA was passed in club to shorten the length of time from a manufacturer'south submission of a New Drug Application or a Biologics License Application to an FDA conclusion approval or licensure.^[7]

Congress created three kinds of user fees via PDUFA and required that they each brand up one-3rd of the total fees collected. These include application review fees paid past the sponsor for each drug or biologic application submitted, institution fees paid past manufacturers annually for each of its facilities, and production fees paid annually for each product on the market place covered by PDUFA. For 1993, the application review fee was nearly $100,000. The law provided exemptions and waivers for applications from modest businesses, drugs aimed at orphan diseases, or unmet public health needs.^[vii]

In gild to avoid listing specific performance goals in statutory language Congress stated in the beak's "Findings" that, "3) the fees authorized past this championship volition be dedicated toward expediting the review of human drug applications as set forth in the goals identified in the letters of September 14, 1992, and September 21, 1992, from the Commissioner of Food and Drugs to the Chairman of the Energy and Commerce Committee of the Firm of Representatives and the Chairman of the Labor and Man Resources Committee of the Senate, as prepare forth at 138 Cong. Rec. H9099-H9100 (daily ed. September 22, 1992)."^[7]

PDUFA II [edit]

In its 1997 reauthorization of PDUFA, Congress enacted stricter performance goals, required increased transparency in the drug review procedure, and tried to facilitate better advice between drug makers and patient advancement groups. Congress expanded the telescopic of the legislation to include the investigational phases of a new drug'due south development. PDUFA Ii was passed equally Title I of the Food and Drug Assistants Modernization Act.^[7]

When Congress was debating the legislation that implemented PDUFA Two Rep. Billy Tauzin, who later on became head of PhRMA and one of those leading the call for a further streamlined review process, told a story of how a family friend had to travel to Mexico to obtain drugs that helped him overcome prostate cancer. "Nosotros continue to accept problems with the fact that approved medicines in other countries tin can't get canonical here. Only what I particularly can't understand at all are situations where y'all have people suffering terminal illnesses, and they tin can't go the experimental drugs that might save their lives."^[eight]

In testimony before Congress, James Swire, an AIDS activist and health educator who became infected with HIV in 1990, said the FDA has dramatically reduced the time needed to approve life-saving drugs using the money from PDUFA. Swire said, "I'thou here because people actually pushed the review process for AIDS and HIV treatments. There still is not a cure, but because of some of the new drugs, a lot of us accept been able to get back to work."^[eight]

PDUFA III [edit]

PDUFA III, part of the Public Health and Bioterrorism Preparedness Act, fabricated appropriations for increased postmarket monitoring of new products and allowed the FDA to hire additional personnel to speed the reviews of new drugs.^[9] Some other 2002 statute extended user fee policies to cover the approval process for medical devices.

During the period that PDUFA Three was in effect the FDA's requirement that drug companies pay user fees for 505(b)(two) applications to switch drugs from requiring a prescription to being sold over-the-counter became a source of controversy. The drug industry claimed that the FDA misinterpreted the department of PDUFA 3 authorizing user fees when deciding to charge for reviewing 505(b)(2) applications. Specifically, they said Congress only intended user fees to exist paid on new indications for a new active ingredient and that switching a drug to over-the-counter status was an exception to the rule requiring user fees.^[10]

In February 2007 the FDA exempted drugs used in the President's Emergency Plan for AIDS Relief (PEPFAR) from user fees in guild to reduce the financial brunt of developing new AIDS drugs.^[11]

PDUFA IV [edit]

The FDA requested and received fee increases to embrace increased reviewer workload and expanded post-marketing safety initiatives, as well equally the dominance to apply user fees to the monitoring of direct-to-consumer drug advertising.^[12] President Bush-league signed the reauthorization of PDUFA into law on 27 September 2007.^[thirteen]

In 2007, the FDA was expected to collect $259,300,000 in industry user fees.^[14]

PDUFA V [edit]

The reauthorization process for PDUFA V began with a public hearing in April 2010. The Pharmaceutical Enquiry and Manufacturers of America (PhRMA) strongly supported reauthorization of PDUFA, saying at the time that "PDUFA Five can play a disquisitional office in making more than life-saving medicines available to patients in a timely manner, strengthening the scientific base of the FDA and providing a steady, reliable stream of resources for Agency scientists."^[xv]

PDUFA was reauthorized in July 2012.^[xvi] PDUFA's fifth reauthorization calls for upgrading benefit/risks assessments of new medicines^[17] too as call for more patient perspectives in the review procedure.^[18]

PDUFA VI [edit]

On Baronial xviii, 2017, President Trump signed into law the Food and Drug Administration Reauthorization Act (FDARA), which includes the reauthorization of PDUFA through September 2022. PDUFA VI volition provide for the continued timely review of new drug and biologic license applications.^[19]

Effectiveness [edit]

Increased staffing [edit]

A 2002 U.South. Regime Accountability Office (GAO) report establish that PDUFA funds immune the FDA to increase the number of new drug reviewers by 77 percentage in the first eight years of the act, and the median approval time for not-priority new drugs dropped from 27 months to 14 months over the aforementioned period.^[9]

Review times [edit]

A major PDUFA goal is for the FDA to review and provide a ruling on applications within one year unless significant changes are made to the application during the final iii months of the review bike. In a 1997 speech given prior to leaving the FDA David Kessler said, "And so far nosotros have reviewed 95% of the 1995 group on fourth dimension. We won't achieve 100%, however, because we did make a mistake: we misread a borderline on a calculator printout and we missed one borderline by 3 days." The PDUFA goal for the 1995 group called for a 70% on-time tape. The 95% on-time charge per unit more than doubled the pre-PDUFA on-time level of about 40%. Kessler said the FDA achieved like positive results with other PDUFA goals, including in its review time for efficacy supplements (requests to add together a new indication or a new grouping of patients to an already approved drug), submissions for manufacturing supplements (for making significant changes in the fashion a drug is fabricated or using a new manufacturing facility) and resubmissions (responses provided to questions or alleged deficiencies raised by the FDA).^[20]

From 1993 through 1996, the years PDUFA I was in consequence, the approval fourth dimension for new drugs declined significantly while the number of new products increased. The approving time for NDAs in the 8 years earlier the implementation of PDUFA I was roughly 31.three months. During this period, the approval time exceeded 30 months in every year except 1990 when it was 27.7 months and 1992 when information technology was 29.9 months. From 1993 through 1996, the average approval fourth dimension fell to 20.8 months. During this flow, the approval time for new drugs never exceeded thirty months.^[21] According to the Pharmaceutical Inquiry and Manufacturers of America drug review fourth dimension was cut roughly in one-half later the passage of PDUFA I.^[22]

Drug launches [edit]

Faster drug approval times and other PDUFA-related changes take led to pharmaceutical companies targeting more drugs for showtime launch in the United States thus increasing patient access to new medicines. Faster drug review from 1990 to 2001 were found to increase the probability of a drug being launched starting time in the United states of america by 14%. Other changes made under PDUFA such equally the increased probability of approval and shortened development periods increased the probability of a drug existence start launched in the U.s.a. by 31 percent at the end of PDUFA I and 27 percent at the terminate of PDUFA II.^[23]

During the viii years before PDUFA took upshot, an average of 24 new drugs were canonical each yr. The number of approvals ranged from 20 in 1988 to thirty in 1991. During the four years that PDUFA I was in effect, an average of 32 drugs were approved each twelvemonth, ranging from 22 in 1994 to 53 in 1996. The boilerplate number of new drugs approved by the FDA each year increased past one-tertiary.^[21]

First drug launches making utilize of new chemical entities in the United States increased from 44 from 1982 through 1992 to 156 in from 1993 through 2003 period. The increase in first drug launches in the United States from 1993 through 2003 is peculiarly interesting given that the Eu harmonized its regulatory regime for new drugs with those of other major markets in order to reduce barriers for drug approvals during the same period.^[23]

Regulator-manufacture communication [edit]

David Kessler described improved communication between the FDA and the drug industry on what information should exist included in NDAs as an important benefit of PDUFA. He said, "For case, in fiscal twelvemonth 1993, 34 of the new applications that came into the FDA were sent back to the company considering they were poorly prepared or missing critical information. In fiscal year 1996 six applications were refused for these reasons – a more than fivefold comeback."^[20]

PDUFA dates [edit]

PDUFA dates are deadlines for the FDA to review new drugs. The FDA is commonly given x months to review new drugs. If a drug is selected for priority review, the FDA is allotted half-dozen months to review the drug. These time frames brainstorm on the appointment that an NDA is accepted by the FDA equally complete.

Scale of fees [edit]

FDA calculates fees based on an annual basis. For fiscal year 2021, drug application fees are:

$two,875,842 per full awarding requiring clinical information,

$1,437,921 per application not requiring clinical data or per supplement requiring clinical information.

$336,432 for programs^[nineteen]

The FDA estimates that operating costs for the year 2017 volition be $878,590,000. The FD&C Act specifies that 1-third of the total fee acquirement is to be derived from application fees, one-third from establishment fees, and one-3rd from production fees (come across section 736(b)(2) of the FD&C Human action). FDA estimates that in 2016, ii,646 products will have been billed for product fees and 523 establishments will have been billed for establishment fees.

In 2015, 132.5 total application equivalents (FAEs) were charged an application fee. FAEs are calculated past counting a full awarding as ane FAE and an application not requiring clinical information or a clinical information supplement every bit one-half an FAE. An application that is withdrawn, or refused for filing, counts as one quarter of the original FAE. For a total application this is one quarter FAE, and for an application without clinical data or a clinical data supplement this is an 8th of an FAE.^[19]

FDA budget [edit]

User fees imposed under PDUFA are expected to add together $707 million to the FDA budget in 2011, roughly a quarter of the bureau'south total spending. User fees encompass roughly 65 pct of the drug approval procedure.^[24]

References [edit]

^ Thaul, Susan (2008). "The Prescription Drug User Fee Human activity (PDUFA): History, Reauthorization in 2007, and Effect on FDA". Congressional Inquiry Service.
^ "ACTUP Capsule History 1988". ACT UP: AIDS Coalition To Unleash Power. ACTUP New York, Inc. Retrieved 17 Feb 2020.
^ Pear, Robert (sixteen August 1990). "Faster Approval of AIDS Drugs Is Urged". The New York Times. Washington, D.C. p. Late Edition – Concluding, Section B, Page 12, Column 4.
^ Part of Special Health Issues (5 March 1998). "Expanded Access and Expedited Approval of New Therapies Related to HIV/AIDS". U.South. Food and Drug Administration. Archived from the original on vii January 2001.
^ Flieger, Ken (Jan 1995). "FDA Consumer special written report: FDA Finds New Ways to Speed Treatments to Patients". U.Southward. Food and Drug Administration. Archived from the original on 8 Feb 2001.
^ Arnold, Matthew (1 October 2006). "Angry patients fight for affordable HIV treatments; AIDS, A CONSUMER REVOLUTION". Medical Marketing & Media.
^ ^a ^b ^c ^d Thaul, Susan (12 July 2007), Prescription Drug User Fee Act (PDUFA), Congressional Research Services Report RL33914, Congressional Enquiry Services
^ ^a ^b Alpert, Bruce (15 June 1997). "Endeavor AFOOT TO QUICKEN DRUG APPROVAL PROCESS; SENATE Panel FACES TOUCHY Debate". Times-Niggling. New Orleans, LA.
^ ^a ^b Food AND DRUG ADMINISTRATION: Effect of User Fees on Drug Approval Times, Withdrawals, and Other Bureau Activities (GAO-02-958) (PDF), Government Accounting Function, September 2002, archived from the original (PDF) on 8 March 2003
^ "DRUGS FIRMS Will LIKELY Run into FDA TO Protestation USER FEES FOR 505(B)(ii)". FDA Week. 12 Baronial 2005.
^ "FDA to Exempt PEPFAR Drugs From User Fees". Washington Drug Letter. 12 February 2007.
^ "Final PDUFA Recommendations Transmitted to Congress Volition Strengthen Drug Review and Drug Safe" (Printing release). U.Southward. Food and Drug Administration. 23 March 2007. Archived from the original on 12 Jan 2008.
^ "PDUFA Legislation and Background". Food and Drug Assistants. Retrieved 22 Feb 2011.
^ "Prescription Drug User Fee Rates for Fiscal Year 2007 [DOCID:fr02au06-96]", Federal Register, Department of Health and Human being Services, Food and Drug Administration, vol. 71, no. 148, pp. 43780–43784, 2 Baronial 2006, archived from the original on 10 August 2007
^ "PhRMA Statement on PDUFA Reauthorization" (Press release). Washington, D.C.: Pharmaceutical Research and Manufacturers of America. 12 April 2010. Archived from the original on 5 March 2011. Retrieved 21 February 2011.
^ "PDUFA 5 Signed Into Police force; Clock Ticking on Enacting Changes". FDA News. WCG. 9 July 2012. Retrieved 17 February 2020.
^ "Enhancing Benefit-Risk Assessment in Regulatory Controlling". FDA.gov. U.S. Food and Drug Assistants. Retrieved seven July 2014.
^ O'Connor, Amy. "PDUFA Five: Route to Implementation". Campaign for Modern Medicines. Eli Lilly and Company. Retrieved seven July 2014.
^ ^a ^b ^c Food and Drug Assistants, U.Due south. Section of Health and Human Services (10 February 2021). "Prescription Drug User Fee Amendments". Federal Annals . Retrieved 17 March 2021. {{cite spider web}}: CS1 maint: url-condition (link)
^ ^a ^b Kessler, David (twenty January 1997). "A valedictory talk by FDA Commissioner David Kessler". Chain Drug Review.
^ ^a ^b Cantor, David J. (1997). "Prescription Drug User Fee Act of 1992: Furnishings On Bringing New Drugs To Market place" (PDF). CRS Report for Congress. Congressional Research Service. Retrieved xiv February 2011.
^ Cox, Therese South. (30 July 1997). "Sufferers say drug human action is vital to living Measure speeds approval of new drugs by federal agency". Charleston Daily Mail (Due west Virginia).
^ ^a ^b Olson, Mary 1000. (2009). "PDUFA AND INITIAL U.S. DRUG LAUNCHES" (PDF). Michigan Telecommunications and Technology Law Review. 15. Archived from the original (PDF) on 6 December 2010. Retrieved 15 February 2011.
^ Dutton, Gail (seven February 2011). "2011 Upkeep Outlook: Trim, Cut, Then Slash". Genetic Applied science & Biotechnology News . Retrieved 15 Feb 2011.