FDA User Fees and Drug Advertising: Dr. Ardis on Drug Approval

Table of Contents

1. What Dr. Ardis Says
2. The Prescription Drug User Fee Act of 1992
3. Five-Year Renewals, PDUFA II to PDUFA VII
4. What the Fees Are Today
5. How Much of Drug Review the Fees Pay For
6. Review Deadlines and What Researchers Found
7. Whose Studies the FDA Reviews
8. Drug Advertising Aimed at Patients
9. What Studies Found About Advertising and Prescribing
10. The September 2025 Federal Actions
11. Safety Notes
12. Dr. Ardis’s Own Work
13. Key Research Papers
14. Connections
15. Featured Videos

1. What Dr. Ardis Says

Dr. Ardis set this out in a 2025 podcast appearance (Culture Apothecary) and in his book Moving Beyond the COVID-19 Lies: Restoring Health and Hope for Humanity. He raises it while asking why, in 1994, the FDA said a warning reading “This product contains nicotine, an addictive substance” should go on tobacco products, and who benefits from that message. His answer is the pharmaceutical industry.

Trust in FDA approval

Dr. Ardis states that everyone in America has been “programmed since we’ve been born” to trust drugs, provided they are FDA approved: FDA approval is what earns a product society’s approval to be bought. In his words, “Big Pharma buys the FDA’s approval for all of their drugs.”

The upfront fee

He says that about thirty years ago the FDA stopped having to carry out the full review process for every drug if the maker paid a lump fee up front. He describes the arrangement as an offer to the drug maker: pay $10 million up front and the drug can go on pharmacy shelves straight away, provided the maker’s own research studies say it will give the greatest benefit to people in America. He adds, of those studies, “trust us, must not be biased at all.” He sums it up: “you give us a $10 million upfront stipend, we’ll just go ahead and approve it.”

Drug commercials

Dr. Ardis says he has raised the subject with Robert F. Kennedy Jr., and asks him to “make sure they take all drug commercials off.” He asks why America is the only country of its size that allows drug products to be advertised directly to consumers.

Who benefits

Later he returns to the question of who benefits from what he calls the lie about nicotine, and answers that the FDA and the pharmaceutical industry do. He lists the conditions he has discussed — Parkinson’s, Alzheimer’s, MS, ulcerative colitis, all arthritis, myocarditis, autism and glioblastoma tumours — and says that “billions of dollars’ worth every year” of FDA-approved drugs are prescribed for them. He states that lobbying money and bribes keep those drugs being prescribed “when there is a curative agent known for all of them, or at least an agent that would improve their symptoms mightily,” that this “has already been proven for decades,” and that the FDA frightened the public about nicotine “because it’s an antidote to so many problems” for which the industry wants people on drugs for the rest of their lives.

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2. The Prescription Drug User Fee Act of 1992

The change Dr. Ardis describes as happening about thirty years ago matches, in date, the Prescription Drug User Fee Act (PDUFA), which Congress passed in 1992. Before it, the FDA’s review of new drug applications was paid for from money Congress appropriated each year. PDUFA let the FDA charge the companies that submit applications a fee, and required the agency in return to meet written performance goals — chiefly, deadlines for finishing its reviews. The first fees were collected in fiscal year 1993.

Under the act a company pays two kinds of fee:

• An application fee, owed when a new drug application or biologics licence application is submitted. It is set at a full rate when the application relies on new clinical data and at half that rate when it does not. The fee is owed on submission, not on approval.
• An annual program fee (called an establishment and product fee in earlier versions) for prescription drug products already approved.

The law also sets a condition known as the “trigger”: Congress must keep appropriating a minimum amount of ordinary budget money for drug review, so that the fees add to that money rather than replace it.

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3. Five-Year Renewals, PDUFA II to PDUFA VII

PDUFA was written to expire after five years, and Congress has renewed it every five years since. The FDA lists the renewals as PDUFA II (1997), PDUFA III (2002), PDUFA IV (2007), PDUFA V (2012), PDUFA VI (2017) and PDUFA VII (2022). Each renewal rewrote the performance goals and the fee formula, and several were carried inside larger FDA laws — the 1997 renewal in the FDA Modernization Act, the 2007 one in the FDA Amendments Act, the 2012 one in the FDA Safety and Innovation Act, and the 2017 one in the FDA Reauthorization Act.

The FDA states that on September 30, 2022, the President signed the FDA User Fee Reauthorization Act of 2022, which renews PDUFA through September 2027. A PDUFA VIII renewal is therefore due before that date.

The first act’s best-known goal was speed: the FDA undertook to finish review of most priority applications in 6 months and standard applications in 12 months. Under PDUFA VII the goals are to act on 90% of applications for new molecular entities within 10 months (standard review) or 6 months (priority review), counted from the 60-day point at which the FDA formally accepts the application for filing.

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4. What the Fees Are Today

The FDA publishes the year’s fees in the Federal Register each summer. The notice “Prescription Drug User Fee Rates for Fiscal Year 2026” (FR Doc. 2025-14413, published July 30, 2025) sets these rates for October 1, 2025 through September 30, 2026:

• An application requiring covered clinical data: $4,682,003
• An application not requiring covered clinical data: $2,341,002
• The annual prescription drug program fee, per product: $442,213

The same notice sets the total revenue the fees are meant to raise in fiscal year 2026 at $1,556,038,000, and states that by law application fees provide 20% of that total and program fees 80%. In other words, most of the money comes from the yearly charge on drugs already on the market, not from the fee paid with a new application.

The full-rate application fee, about $4.7 million for fiscal year 2026, is the published figure closest to the “$10 million upfront stipend” Dr. Ardis describes. The Federal Register notice is linked under External Authoritative Resources below.

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5. How Much of Drug Review the Fees Pay For

A 2020 review in JAMA by Jonathan Darrow, Jerry Avorn and Aaron Kesselheim of Harvard Medical School traced FDA drug regulation from 1983 to 2018, including the user fees paid by industry from 1993 onward. They report that PDUFA fees collected from industry rose from an annual average of $66 million in 1993–1997 to $820 million in 2013–2017, and that in 2018 user fees accounted for approximately 80% of the salaries of the review staff responsible for approving new drugs. They also report that user-fee funding, which began with new drugs and biologics in 1992, was extended to generic and biosimilar drugs in 2012.

The same review documents other changes over those 35 years: FDA review times fell from more than three years in 1983 to less than one year in 2017, while the total time from the start of human testing to approval stayed at about eight years; the share of new approvals supported by at least two pivotal trials fell from 80.6% (1995–1997) to 52.8% (2015–2017); and 81% of new drugs approved in 2018 used at least one expedited program (Accelerated Approval, Fast Track or Priority Review). The authors conclude that the funding needed for these programs “has been addressed by expanding industry-paid user fees,” and that the FDA “has increasingly accepted less data and more surrogate measures, and has shortened its review times.”

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6. Review Deadlines and What Researchers Found

Because PDUFA tied the fees to review deadlines, researchers have asked whether faster reviews changed what reached the market. The main studies, as they read:

• Staffing and speed (2003). Daniel Carpenter and colleagues studied 843 new drug applications submitted from 1977 to 2000. Review time shortened by 3.3 months for every 100 additional FDA staff, and they concluded that the amount of money for staff mattered much more to review time than whether it came from fees or from Congress.
• Deadlines and later safety problems (2008). Carpenter, Zucker and Avorn, writing in the New England Journal of Medicine, found that the PDUFA deadlines bunched approval decisions into the weeks just before each deadline. Drugs approved in the two months before their deadline were more likely than drugs approved at other times to be withdrawn later for safety reasons (odds ratio 5.5), to receive a later black-box warning (odds ratio 4.4) and to have a dosage form voluntarily discontinued (odds ratio 3.3).
• Review speed and adverse reactions (2008). Mary Olson, an economist at Tulane, studied drugs approved from 1990 to 2001 and found that drugs receiving faster reviews were associated with more reports of serious adverse reactions, after allowing for how widely each drug was used and for other factors. She wrote that any increase in risk must be weighed against benefits, and that the results show a trade-off between review speed and safety.
• Three agencies compared (2012). Nicholas Downing and colleagues at Yale compared reviews of novel drugs approved from 2001 to 2010 by the FDA, the European Medicines Agency and Health Canada. The FDA’s median first review took 303 days, against 366 at the European agency and 352 at Health Canada, and most of the drugs approved in more than one place were approved first in the United States.

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7. Whose Studies the FDA Reviews

Dr. Ardis’s account turns on the point that approval rests on the drug maker’s own studies. That is how the system is built in law. Since the 1962 Kefauver–Harris Amendments, a company seeking approval must show “substantial evidence” of effectiveness from adequate and well-controlled investigations, along with evidence of safety. The company (the “sponsor”) designs, runs and pays for those trials, usually through contracted investigators, and submits the results; FDA reviewers examine the data, including individual patient records, and may inspect trial sites. User fees did not change who carries out the trials. They pay for the FDA staff who review them.

The Darrow review (section 5) documents how the amount of trial evidence behind approvals has changed, including more approvals based on a single pivotal trial and on surrogate measures — laboratory or imaging results used in place of outcomes such as survival — while the median number of patients studied before approval stayed about the same (774 versus 816).

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8. Drug Advertising Aimed at Patients

Dr. Ardis asks why America is the only country of its size to allow drug advertising aimed directly at consumers. Published research describes the same picture: a 2015 study in BMC Health Services Research by Tim Mackey and colleagues notes that direct-to-consumer advertising of prescription drugs is legally allowed only in the United States and New Zealand.

In the United States the FDA regulates prescription drug advertising under the Federal Food, Drug, and Cosmetic Act. A print advertisement must carry a “brief summary” of the drug’s risks. For broadcast advertisements, the law requires the major risks to be stated and allows the rest of the information to be made available by “adequate provision” rather than read out in full. In August 1997 the FDA issued draft guidance explaining that a television or radio advertisement could meet that requirement by pointing viewers to a toll-free number, a website, a print advertisement and their doctor or pharmacist; the guidance was finalised in 1999. Product-specific television drug commercials grew rapidly after 1997.

How much is spent

• Lisa Schwartz and Steven Woloshin of Dartmouth reviewed medical marketing in the United States from 1997 to 2016 in JAMA (2019). Spending on direct-to-consumer prescription drug advertising rose from $1.3 billion (79,000 advertisements) in 1997 to $6 billion (4.6 million advertisements, including 663,000 television commercials) in 2016, in 2016 dollars. Marketing aimed at health professionals was still larger, rising from $15.6 billion to $20.3 billion, most of it free samples. Over the same period the number of FDA violation letters for misleading drug marketing fell from 156 to 11.
• Julie Donohue and colleagues, in the New England Journal of Medicine (2007), found that direct-to-consumer advertising spending rose 330% from 1996 to 2005 but was still only 14% of total drug promotion spending in 2005; that such campaigns usually began within a year of a drug’s FDA approval; and that FDA letters about advertising violations fell from 142 in 1997 to 21 in 2006.

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9. What Studies Found About Advertising and Prescribing

• Sacramento and Vancouver (2002–2003). Barbara Mintzes and colleagues surveyed 1,431 adult patients and their 78 family doctors in Sacramento, California, where such advertising is legal, and Vancouver, British Columbia, where it is not. Patients in Sacramento asked for advertised drugs more often (7.2% against 3.3%). Doctors fulfilled most of those requests in both cities, and patients who asked for an advertised drug were far more likely to leave with at least one new prescription (odds ratio 16.9). Doctors rated half of the prescriptions written for requested drugs as only “possible” or “unlikely” choices for a similar patient, against 12.4% of prescriptions patients had not asked for. A short report appeared in the BMJ in 2002 and the full study in the Canadian Medical Association Journal in 2003.
• Actors asking for antidepressants (2005). Richard Kravitz and colleagues sent trained actors posing as patients on 298 unannounced visits to 152 primary-care doctors in Sacramento, San Francisco and Rochester, New York. Playing someone with major depression, actors who asked for a drug by brand name were prescribed an antidepressant 53% of the time, those who asked generally 76%, and those who did not ask 31%. Playing someone with adjustment disorder, the figures were 55%, 39% and 10%. The authors wrote that advertising may work both ways — helping people who would otherwise go untreated and encouraging treatment that is not needed.

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10. The September 2025 Federal Actions

On September 9, 2025, the President signed a memorandum directing HHS to ensure transparency and accuracy in direct-to-consumer prescription drug advertisements, and the FDA announced what it called a crackdown on deceptive drug advertising. According to the FDA’s announcement:

• the agency was sending about 100 cease-and-desist letters to companies over deceptive advertisements, and thousands of letters to drug companies warning them to remove misleading advertisements;
• it was beginning rulemaking to close the “adequate provision” loophole created in 1997 (section 8), under which broadcast advertisements can leave out much of the risk information;
• it would use artificial intelligence and other tools to monitor advertisements; and
• its enforcement letters had fallen from more than 100 a year to one in 2023 and none in 2024.

FDA Commissioner Marty Makary was quoted in the announcement: “Drug companies spend up to 25% of their budget on advertising. Those billions of dollars would be better spent on lowering drug prices for everyday Americans.” HHS Secretary Robert F. Kennedy Jr., whom Dr. Ardis addresses, led the department at the time.

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11. Safety Notes

Dr. Ardis presents nicotine as the agent being kept from patients with the conditions he lists. Anyone reading further into that work should know that nicotine is a poison at high doses:

• Nicotine patches, gums, lozenges and e-liquids can seriously poison a child or a pet. Keep them out of reach, and fold a used patch sticky side in before throwing it away; a used patch still contains nicotine.
• Nicotine is not for use in pregnancy or while breastfeeding, or by people with unstable heart disease, a recent heart attack or stroke, serious heart-rhythm problems or uncontrolled high blood pressure, among others.
• Do not stop a prescribed medicine on the strength of this page. Talk to the prescriber first.

The full list of contraindications is on the Nicotine Patch Protocol page.

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12. Dr. Ardis’s Own Work

• Moving Beyond the COVID-19 Lies: Restoring Health and Hope for Humanity — the site’s page on his book.
• Dr. Bryan Ardis Hub — his nicotine hypothesis, snake-venom theory and every page in this wing.
• The Dr. Ardis Show — official site

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Key Research Papers

1. Darrow JJ, Avorn J, Kesselheim AS (2020). FDA Approval and Regulation of Pharmaceuticals, 1983-2018. JAMA. — PubMed PMID: 31935033
2. Carpenter D, Chernew M, Smith DG, Fendrick AM (2003). Approval times for new drugs: does the source of funding for FDA staff matter? Health Aff (Millwood). — PubMed PMID: 15506165
3. Carpenter D, Zucker EJ, Avorn J (2008). Drug-review deadlines and safety problems. N Engl J Med. — PubMed PMID: 18367738
4. Olson MK (2008). The risk we bear: the effects of review speed and industry user fees on new drug safety. J Health Econ. — PubMed PMID: 18207263
5. Downing NS, Aminawung JA, Shah ND, Braunstein JB, Krumholz HM, Ross JS (2012). Regulatory review of novel therapeutics—comparison of three regulatory agencies. N Engl J Med. — PubMed PMID: 22591257
6. Schwartz LM, Woloshin S (2019). Medical Marketing in the United States, 1997-2016. JAMA. — PubMed PMID: 30620375
7. Donohue JM, Cevasco M, Rosenthal MB (2007). A decade of direct-to-consumer advertising of prescription drugs. N Engl J Med. — PubMed PMID: 17699817
8. Mackey TK, Cuomo RE, Liang BA (2015). The rise of digital direct-to-consumer advertising?: Comparison of direct-to-consumer advertising expenditure trends from publicly available data sources and global policy implications. BMC Health Serv Res. — PubMed PMID: 26084705
9. Mintzes B, Barer ML, Kravitz RL, et al. (2002). Influence of direct to consumer pharmaceutical advertising and patients' requests on prescribing decisions: two site cross sectional survey. BMJ. — PubMed PMID: 11823361
10. Mintzes B, Barer ML, Kravitz RL, et al. (2003). How does direct-to-consumer advertising (DTCA) affect prescribing? A survey in primary care environments with and without legal DTCA. CMAJ. — PubMed PMID: 12952801
11. Kravitz RL, Epstein RM, Feldman MD, et al. (2005). Influence of patients' requests for direct-to-consumer advertised antidepressants: a randomized controlled trial. JAMA. — PubMed PMID: 15855433

PubMed Topic Searches

1. PubMed: Prescription Drug User Fee Act
2. PubMed: FDA review time and drug safety
3. PubMed: Direct-to-consumer advertising of prescription drugs

External Authoritative Resources

• FDA: Prescription Drug User Fee Amendments — the PDUFA history and the 2022 renewal through September 2027.
• Federal Register: Prescription Drug User Fee Rates for Fiscal Year 2026 (FR Doc. 2025-14413, July 30, 2025) — the fee figures in section 4.
• FDA: FDA Launches Crackdown on Deceptive Drug Advertising (September 9, 2025) — section 10.

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Connections

• Dr. Bryan Ardis Hub — the wing’s main page: his nicotine hypothesis and snake-venom theory
• Tobacco Suppression History — his account of how nicotine came to be feared, including the 1994 FDA warning
• The Nicotine Hypothesis — the antidote argument this page’s closing passage rests on
• Hospital Protocol Critique — his account of FDA-approved hospital treatment
• Dietary Nicotine and Parkinson’s — the first condition on his list
• Nicotine and Ulcerative Colitis — another condition he names
• Nicotine Patch Protocol — the full contraindications and safety notes
• Moving Beyond the COVID-19 Lies — his book
• United States vs European Union: Food Safety Regulation Compared — another place American rules differ from Europe’s
• Hidden Prescription Drugs in “Natural” Supplements — the FDA’s role on the supplement side
• Parkinson’s Disease — the site’s main page on the condition
• Ulcerative Colitis — the site’s main page on the condition

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