For pharmaceutical companies, it takes billions of dollars to develop a new medication, along with years of research and revisions to achieve regulatory approval. Drug manufacturers want to maintain the profits and rights to their flagship medications, attempting to protect profits, patent products and block less expensive generic versions.
That’s one of the reasons Americans pay the most for prescription drugs in the world.
Congress passed a law requiring drug companies to provide samples of their products, which would allow for the development of generic equivalents. This intention is to increase competition and ultimately lower drug prices.
Samples are required for bioequivalence testing, which is necessary for a generic drug to be approved. By refusing to provide samples, the companies are delaying the formulation and availability of cheaper options.
Which companies are blocking generic drugs?
The U.S. Food and Drug Administration (FDA) has publicly released a list of companies that may be intentionally delaying generic drugs. As part of the FDA’s Drug Competition Action Plan (DCAP) to support government efforts for affordable medications, the agency is focusing on transparency.
The FDA has received more than 150 inquiries from generic drug makers looking to access samples from manufacturers. Some companies that have yet to comply include GlaxoSmithKline, Pfizer, Valeant Pharmaceuticals International, BioMarin Pharmaceutical, Gilead Sciences and Novartis Pharmaceuticals.
What drugs are being blocked from generic development?
Many of the drugs manufactured by these companies are necessary or life-saving medications. One medication, Revlimid (lenalidomide), which treats multiple myeloma and other related diseases, currently costs $20,000 a month. Tracleer (bosentan), which is used to treat pulmonary arterial hypertension, costs $12,000 a month, according to GoodRx.
Other drugs include Truvada, the blockbuster medication used to prevent HIV infection, and Clozaril, which is used to treat schizophrenia and suicidal thinking. Also listed is Accutane, a treatment for severe cystic acne.
To urge compliance from manufacturers, the FDA has listed the companies who have yet to provide samples for generics:
Drug Name Drug Manufacturer Absorica (isotretinoin) RANBAXY INC/SUN PHARMACEUTICAL INDUSTRIES INC Abstral (fentanyl citrate) GALENA BIOPHARMA Accutane (isotretinoin) ROCHE PALO ALTO LLC Adempas (riociguat) BAYER HEALTHCARE PHARMACEUTICALS INC Afinitor (everolimus) NOVARTIS PHARMACEUTICALS CORP Amnesteem (isotretinoin) MYLAN PHARMACEUTICALS INC Ampyra (dalfampridine) ACORDA THERAPEUTICS INC Brilinta (ticagrelor) ASTRAZENECA LP Claravis (isotretinoin) TEVA PHARMACEUTICALS USA Clozaril (clozapine) HERITAGE LIFE SCIENCES BARBADOS INC Cystadane (betaine hydrochloride) ORPHAN EUROPE SARL Embeda (morphine sulfate; naltrexone hydrochloride) ALPHARMA PHARMACEUTICALS LLC KING PHARMACEUTICALS Entereg (alvimopan) CUBIST PHARMACEUTICALS INC Exjade (deferasirox) NOVARTIS PHARMACEUTICALS CORP Fazaclo ODT (clozapine) JAZZ PHARMACEUTICALS III INTERNATIONAL LTD Fentora (fentanyl citrate) CEPHALON INC Ferriprox (deferiprone) APOPHARMA INC Firazyr (icatibant acetate) SHIRE ORPHAN THERAPIES INC Gattex Kit (teduglutide recombinant) NPS PHARMACEUTICALS INC Gilotrif (afatinib dimaleate) BOEHRINGER INGELHEIM H.P. Acthar Gel (corticotropin) QUESTCOR PHARMACEUTICALS INC Hemabate (carboprost tromethamine) PHARMACIA AND UPJOHN CO Juxtapid (lomitapide mesylate) AEGERION PHARMACEUTICALS INC Korlym (mifepristone) CORCEPT THERAPEUTICS INC Kuvan (sapropterin dihydrochloride) BIOMARIN PHARMACEUTICAL INC Letairis (ambrisentan) GILEAD SCIENCES INC Methadone Hydrochloride (methadone hydrochloride) ROXANE LABORATORIES INC Mifeprex (mifepristone) DANCO LABORATORIES LLC Nexavar (sorafenib tosylate) BAYER HEALTHCARE PHARMACEUTICALS INC Onsolis (fentanyl citrate) MEDA PHARMACEUTICALS INC Opsumit (macitentan) ACTELION PHARMACEUTICALS LTD Orfadin (nitisinone) SWEDISH ORPHAN BIOVITRUM AB PUBL Pomalyst (pomalidomide) CELGENE CORP Promacta (eltrombopag olamine) GLAXOSMITHKLINE Qsymia (phentermine hydrochloride; topiramate) VIVUS INC Ravicti (glycerol phenylbutyrate) HYPERION THERAPEUTICS INC Revlimid (lenalidomide) CELGENE CORP Sabril (vigabatrin) for solution LUNDBECK LLC / LUNDBECK PHARMACEUTICALS LLC Sabril (vigabatrin) tablet LUNDBECK LLC / LUNDBECK PHARMACEUTICALS LLC Subsys (fentanyl) INSYS THERAPEUTICS INC Tasigna (nilotinib hydrochloride monohydrate) NOVARTIS PHARMACEUTICALS CORP Tecfidera (dimethyl fumarate) BIOGEN IDEC INC Thalomid (thalidomide) CELGENE CORP Tikosyn (dofetilide) PFIZER PHARMACEUTICALS PRODUCTION CORP LTD Tracleer (bosentan) ACTELION PHARMACEUTICALS LTD Truvada (emtricitabine; tenofovir disoproxil fumarate) GILEAD SCIENCES INC Tykerb (lapatinib ditosylate) SMITHKLINE BEECHAM CORP DBA GLAXOSMITHKLINE Veletri (epoprostenol sodium) ACTELION PHARMACEUTICALS LTD Xenazine (tetrabenazine) VALEANT INTERNATIONAL BERMUDA/VALEANT PHARMACEUTICALS NORTH AMERICA LLC Zavesca (miglustat) ACTELION PHARMACEUTICALS LTD Zortress (everolimus) NOVARTIS PHARMACEUTICALS CORP
For more information, please review the Reference Listed Drug (RLD) Access Inquiries or visit FDA. gov.