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.