How many drugs are approved in the US?
FDA regulates about 75 percent of the U.S. food supply. This includes everything we eat except for meat, poultry, and some egg products. There are over 19,000 prescription drug products approved for marketing. FDA oversees over 6,000 different medical device product categories.
Developing new drugs is a costly and uncertain process, and many potential drugs never make it to market. Only about 12 percent of drugs entering clinical trials are ultimately approved for introduction by the FDA.
Since its inception, more than 290 new drugs and biologics to treat serious or life-threatening illnesses have been approved through the accelerated approval program.
A team of CDER physicians, statisticians, chemists, pharmacologists, and other scientists reviews the company's data and proposed labeling. If this independent and unbiased review establishes that a drug's health benefits outweigh its known risks, the drug is approved for sale.
This report lists all of CDER's novel drug approvals of 2017 and also discusses those that CDER considers notable advances. In 2017, CDER approved 46 novel drugs, either as new molecular entities (NMEs) under New Drug Applications (NDAs), or as new therapeutic biologics under Biologics License Applications (BLAs).
The FDA approved 37 novel drugs in 2022, the fewest to pass regulatory scrutiny since 2016. Last year the FDA's Center for Drug Evaluation and Research (CDER) approved 37 novel drugs. This is a drop from the highs of the past 5 years, and brings the rolling 5-year average down to 49 drugs per year.
Overall success rates from Phase I to FDA approval is nearly 9%.
| Total Number of Small Molecule Drugs | 12695 |
|---|---|
| Total Number of Approved Drugs | 4374 |
| Total Number of Approved Small Molecule Drugs | 2761 |
| Total Number of Nutraceutical Drugs | 135 |
| Total Number of Experimental Drugs | 6723 |
A recent study by the Biotechnology Innovation Organization of clinical success rates in advancing drugs to market between 2006 and 2015 found that only 9.6% of drugs entering phase I clinical testing will reach the market (4). Following phases II and III, 30.7% and 58.1% of drugs fail, respectively (4).
FDA Approval is Required by Law
Federal law requires all new drugs in the U.S. be shown to be safe and effective for their intended use prior to marketing. However, some drugs are available in the U.S. even though they have never received the required FDA approval.
Are all drugs approved by the FDA?
Short answer: Unapproved drugs are prescription medications that haven't been approved by the FDA. Today, the FDA needs to approve new prescription medications before they're available. But this wasn't always the case. The Food, Drug, and Cosmetic Act of 1938 required new drugs to show they're safe.
The FDA must regulate and approve new prescription drugs before they can be sold to the public.
Moreover, on average, the total number of prescription purchases (including refills) increased as age category increased for persons ages 0–74 (age category 0–4 (3.9 total prescriptions), age category 5–17 (5.9 total prescriptions), age category 18–44 (9.3 total prescriptions), age category 45–64 (21.6 total ...
This year showed the highest number of new drug approvals in the last two decades. Among the 59 drugs approved in 2018, 14 drugs are considered breakthroughs, which revive hope for many poorly managed diseases. The list also contains 19 drugs that are first in class and 43 that were given priority reviews.
The Federal Food, Drug, and Cosmetic (FDC) Act of 1938 is passed by Congress, containing new provisions: Extending control to cosmetics and therapeutic devices. Requiring new drugs to be shown safe before marketing-starting a new system of drug regulation.
The 10-year graph below shows that from 2013 through 2022, CDER has averaged about 43 novel drug approvals per year. CDER identified 20 of the 37 novel drugs approved in 2022 (54%) as first-in-class.
With more than 8,000 medicines in development, 74% of which are potentially first-in-class, patients have more reasons to be optimistic than ever before. Medicines and vaccines are being developed across dozens of therapeutic areas – including COVID-19, cancer, diabetes, cardiovascular, Alzheimer's disease and more.
So, what of the 90%?
Drugs 'fail' at every stage of development and for several reasons. For every 100 possible drugs that even get to the animal testing stage, some 5,000 other compounds have already been eliminated.
Hemgenix. Priced at roughly $3.5 million, CSL Behring manufactures the world's most expensive drug, Hemgenix. On November 22, 2022, the FDA approved Hemgenix, the first gene therapy for adults with hemophilia B, otherwise known as congenital factor IX deficiency.
Cambridge, Mass., January 31, 2018––A new study* by researchers at the Massachusetts Institute of Technology found that nearly 14% of all drugs in clinical trials eventually win approval from the FDA-an amount that is much higher than previous studies indicate.
How much does FDA approval cost?
FDA Costs and Consulting Service Fees. How Much Does a FDA 510k Approval Cost? The vast majority of our FDA 510K clients generally spend in the range of $20,000-$30,000 to have their product or device prepared and reviewed before the actual FDA 510k submission process.
| Rank | Drug Name | Total Prescriptions (2020) |
|---|---|---|
| 1 | Atorvastatin | 114,509,814 |
| 2 | Levothyroxine | 98,970,640 |
| 3 | Metformin | 92,591,486 |
| 4 | Lisinopril | 88,597,017 |
The United States of America (USA) has the distinction of being the largest producer of medicines in the world. Some experts even consider it the best country for the pharmaceutical industry due to the advancements in technology taking place in the country.
As shown in Figures 3 and 4, the United States accounted for roughly 42% of prescription drug spending and 40% of the GDP among NME innovator countries and was responsible for the development of 43.7% of the NMEs.
The clinical drug development failure due to the lack of efficacy often does not mean the drug candidates do not work, but it is most likely because these drugs could not show satisfactory efficacy in the disease-targeted organs even at maximal tolerable dose (MTD) that already showed toxicity in healthy organs.
References
- https://www.federalregister.gov/agencies/drug-enforcement-administration
- https://www.usp.org/sites/default/files/fda-exhibit/legislation/1938.html
- https://pharmanewsintel.com/news/fundamentals-of-the-pharmaceutical-supply-chain
- https://www.ncbi.nlm.nih.gov/books/NBK236093/
- https://www.americanpharmaceuticalreview.com/Featured-Articles/359768-Critical-Quality-Attributes-Assessment-and-Testing-Strategy-for-Biotherapeutics-Development/
- https://phrma.org/Scientific-Innovation/In-The-Pipeline
- https://www.wsj.com/us-news/oregon-decriminalized-hard-drugs-it-isnt-working-78ee7476
- https://www.fda.gov/media/133830/download
- https://www.fda.gov/drugs/drug-supply-chain-integrity/drug-supply-chain-security-act-dscsa
- https://www.fiercepharma.com/pharma/from-old-behemoth-lipitor-to-new-king-humira-u-s-best-selling-drugs-over-25-years
- https://www.meps.ahrq.gov/data_files/publications/st245/stat245.pdf
- https://www.fda.gov/media/116304/download
- https://www.fda.gov/federal-state-local-tribal-and-territorial-officials/fda-contacts-regulatory-partners
- https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2866602/
- https://www.coursera.org/articles/quality-assurance-vs-quality-control
- https://www.svarlifescience.com/services/bioanalytical-services/potency-testing
- https://www.statnews.com/2020/11/03/should-fda-be-independent/
- https://www.fda.gov/about-fda/fda-basics/fda-fundamentals
- https://www.fda.gov/about-fda/what-we-do
- https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6609997/
- https://www.bu.edu/articles/2023/judge-ruling-abortion-pill-impact-fda-approved-drugs/
- https://www.fda.gov/about-fda/histories-fda-regulated-products/history-drug-regulation
- https://pubmed.ncbi.nlm.nih.gov/34662058/
- https://www.fda.gov/drugs/drug-supply-chain-security-act-dscsa/what-do-i-need-know-about-supply-chain-security-requirements-under-drug-supply-chain-security-act
- https://www.optelgroup.com/en/blog/drug-supply-chain-security-act-dscsa/
- https://www.fda.gov/
- https://study.com/learn/lesson/pharmacology-terms-potency-efficacy-affinity.html
- https://www.fda.gov/about-fda/office-policy-legislation-and-international-affairs/office-legislation
- https://lifesciencesintelligence.com/features/the-top-5-most-expensive-fda-approved-gene-therapies
- https://www.law.cornell.edu/wex/commerce_clause
- https://www.eurofinsus.com/food-testing/resources/usda-vs-fda-food-labeling/
- https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9907423/
- https://www.fda.gov/about-fda/fda-organization/fda-organization-charts
- https://alirahealth.com/education-hub/critical-quality-attributes-for-drug-products/
- https://www.upm-inc.com/why-is-pharmaceutical-quality-assurance-important
- https://www.fda.gov/media/164429/download
- https://www.asq.org/cert/resource/pdf/certification/FactSheets/CQA%20Fact%20Sheet.pdf
- https://www.pharmacytimes.com/view/pharmacies-gear-up-for-dscsa-interoperability-go-live-deadline
- https://www.dea.gov/drug-information/csa
- https://www.nature.com/articles/s41591-020-01200-w
- https://www.fda.gov/about-fda/fda-organization
- https://clincalc.com/DrugStats/Top300Drugs.aspx
- https://constitutioncenter.org/the-constitution/articles/article-i/clauses/752
- https://www.fda.gov/about-fda/changes-science-law-and-regulatory-authorities/fdas-origin
- https://www.fda.gov/about-fda/changes-science-law-and-regulatory-authorities/part-i-1906-food-and-drugs-act-and-its-enforcement
- https://www.bio.org/media/press-release/new-study-shows-rate-drug-approvals-lower-previously-reported
- https://www.linkedin.com/pulse/fda-delays-dscsa-drug-supply-chain-security
- https://rarediseases.org/wp-content/uploads/2014/12/NORD-TimeLine.pdf
- https://www.azonano.com/article.aspx?ArticleID=6283
- https://www.nichd.nih.gov/health/topics/pharma/conditioninfo/approval
- https://oig.hhs.gov/oei/reports/oei-09-00-00380.pdf
- https://www.understandinganimalresearch.org.uk/news/why-do-90-of-new-drugs-fail
- https://www.fda.gov/files/about%20fda/published/2017-New-Drug-Therapy-Approvals-Report.pdf
- https://www.mcguirewoods.com/client-resources/alerts/2013/12/drug-quality-and-security-act/
- https://www.fda.gov/about-fda/fda-commissioner
- https://www.fda.gov/media/115824/download
- https://www.sciencedirect.com/topics/engineering/key-process-parameter
- https://www.fda.gov/media/104094/download
- https://crsreports.congress.gov/product/pdf/R/R44782
- https://blog.tracktracerx.com/will-affected-dscsa
- https://pubmed.ncbi.nlm.nih.gov/21698778/
- https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4070262/
- https://pubmed.ncbi.nlm.nih.gov/665689/
- https://library.weill.cornell.edu/about-us/snake%C2%A0oil%C2%A0-social%C2%A0media-drug-advertising-your-health/food-and-drug-administration-continued
- https://crstoday.com/articles/2011-oct/a-brief-history-of-the-fda
- https://www.fda.gov/about-fda/economics-staff/fda-glance
- https://blog.tracktracerx.com/hda-updates-their-q/a-for-the-dscsa
- https://www.fda.gov/about-fda/fda-basics/what-does-fda-regulate
- https://pqri.org/wp-content/uploads/2015/10/01-How-to-identify-CQA-CPP-CMA-Final.pdf
- https://www.fda.gov/about-fda/fda-history/milestones-us-food-and-drug-law
- https://www.fda.gov/drugs/drug-supply-chain-security-act-dscsa/fda-announces-proposed-rule-national-standards-licensure-wholesale-drug-distributors-and-third-party
- https://www.fda.gov/regulatory-information/search-fda-guidance-documents/q8-q9-q10-questions-and-answers-appendix-qas-training-sessions-q8-q9-q10-points-consider
- https://blog.perkinelmer.com/posts/the-four-pillars-of-critical-quality-attributes/
- https://www.cbo.gov/publication/57126
- https://www.usa.gov/agencies/food-and-drug-administration
- https://www.fda.gov/media/148197/download
- https://en.wikipedia.org/wiki/History_of_the_Food_and_Drug_Administration
- https://mitsloan.mit.edu/press/measuring-risks-and-rewards-drug-development-new-research-mit-shows-success-rates-clinical-trials-are-higher-previously-thought
- https://www.goodrx.com/drugs/medication-basics/what-are-unapproved-drugs
- https://www.qualifyze.com/resources/blog/what-is-the-pharmaceutical-supply-chain/
- https://www.supplychaindive.com/news/pharmaceutical-traceability-law-DSCSA-delayed-2024-healthcare-supply-chain/693431/
- https://en.wikipedia.org/wiki/An_act_to_regulate_the_time_and_manner_of_administering_certain_oaths
- https://scholarship.law.campbell.edu/cgi/viewcontent.cgi?article=1222&context=clr
- https://www.fda.gov/about-fda/fda-basics/when-and-why-was-fda-formed
- https://en.wikipedia.org/wiki/Drug_Quality_and_Security_Act
- https://go.drugbank.com/stats
- https://oig.hhs.gov/oei/reports/oei-03-90-02300.pdf
- https://www.fda.gov/media/109482/download
- https://www.fda.gov/drugs/enforcement-activities-fda/unapproved-drugs
- https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3151195/
- https://www.fda.gov/regulatory-information/fda-rules-and-regulations
- https://en.wikipedia.org/wiki/Office_of_Criminal_Investigations
- https://www.hamiltoncompany.com/process-analytics/process-analytical-technology/critical-process-parameters
- https://www.fda.gov/drugs/drug-safety-and-availability/dscsa-compliance-policies-establish-1-year-stabilization-period-implementing-electronic-systems
- https://landmarkrecovery.com/history-of-us-drug-enforcement/
- https://www.fda.gov/drugs/cder-small-business-industry-assistance-sbia/fda-related-laws-regulations-and-guidances
- https://www.dda.gov.np/content/about-us
- https://www.whitehouse.gov/about-the-white-house/our-government/the-legislative-branch/
- https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3066341/
- https://www.fda.gov/drugs/drug-supply-chain-security-act-dscsa/pharmacists-utilize-dscsa-requirements-protect-your-patients
- https://www.nature.com/articles/d41573-023-00001-3
- https://www.fda.gov/industry/fda-user-fee-programs/fda-user-fees-explained
- https://finance.yahoo.com/news/top-16-medicine-producing-countries-120134464.html
- https://en.wikipedia.org/wiki/Food_and_Drug_Administration
- https://www.quora.com/Is-the-FDA-constitutional
- https://www.ncbi.nlm.nih.gov/books/NBK582130/
- https://www.fda.gov/about-fda/fda-history-exhibits/80-years-federal-food-drug-and-cosmetic-act
- https://www.fda.gov/drugs/development-approval-process-drugs
- https://www.sqmgroup.com/resources/library/blog/customer-quality-assurance-cqa
- https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4911992/
- https://www.cardinalhealth.com/content/dam/corp/web/documents/brochure/CardinalHealth-DrugTracingFAQsCustomers.pdf
- https://www.sciencedirect.com/topics/agricultural-and-biological-sciences/pure-food-and-drug-act
- https://510kfda.com/pages/fda-510k-costs
- https://www.fda.gov/about-fda/changes-science-law-and-regulatory-authorities/fdas-legal-authority
- https://press.princeton.edu/books/paperback/9780691141800/reputation-and-power
- https://www.hamiltoncompany.com/process-analytics/process-analytical-technology/critical-quality-attributes
- https://www.altersis-performance.com/continuous-quality-assurance/
- https://slcontrols.com/qbd-cqa-cpp-pat-understanding-process-validation-terminology/
- https://www.fda.gov/media/151975/download
- https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9293739/
- https://www.visitthecapitol.gov/exhibitions/congress-and-progressive-era/pure-food-and-drug-act
- https://ncs-conference.org/wp-content/uploads/2022/12/Lamerz-D3-20m-V2-An-update-on-Roche_s-experience-with-the-Impact-Ratio-year-six.pdf
- https://www.lilly.com/news/stories/accelerated-approval-get-needed-treatments-patients
- https://pubmed.ncbi.nlm.nih.gov/31793428/
- https://www.arlok.com/news/stability-versus-potency-testing
- https://medium.com/@sajiveva1112000/understanding-the-four-types-of-quality-assurance-for-exceptional-results-bef3168060fc
- https://www.fda.gov/medical-devices/home-use-devices/fdas-role-regulating-medical-devices
