The Federal Trade Commission issues a policy statement declaring that improper patent listings in the FDA’s ‘Orange Book’ (Approved Drug Products with Therapeutic Equivalence Evaluations) constitute potential unfair methods of competition under Section 5 of the FTC Act or unlawful …
FTCAndrew N. FergusonFDAAmphastarMylan+2 moreintellectual-propertypharmaceutical-patentspatent-evergreeningorange-bookftc+3 more
U.S. District Judge Edward Davila sentences Theranos founder Elizabeth Holmes to 135 months (11 years, 3 months) in federal prison plus three years supervised release for defrauding investors of over $140 million. Holmes is ordered to surrender on April 27, 2023 to begin serving her sentence. …
Elizabeth HolmesEdward DavilaU.S. Department of JusticeTheranosFDA+1 morecorruptionfraudregulatory-capturetechhealthcare+3 more
A federal jury convicts Theranos founder Elizabeth Holmes on one count of conspiracy to commit investor fraud and three counts of wire fraud involving over $140 million in investments. The conviction follows a nearly four-month trial where prosecutors presented testimony from 29 witnesses …
Elizabeth HolmesTheranosU.S. Department of JusticeSecurities and Exchange Commission (SEC)FDAcorruptionfraudregulatory-capturetechhealthcare+3 more
Dr. Stephen Hahn, former FDA Commissioner who led the agency during COVID-19 vaccine emergency use authorizations, joined Flagship Pioneering as Chief Medical Officer on June 16, 2021. The move came six months after the FDA granted emergency use authorization to Moderna’s COVID-19 vaccine. …
Stephen HahnFlagship PioneeringModernaFDAregulatory-capturepharmaceutical-industryconflict-of-interestcovid-pandemicfda-oversight
AbbVie reached settlement agreements with eight biosimilar manufacturers that allowed immediate biosimilar competition in Europe starting October 16, 2018, but delayed all US market entry until 2023—seven years after Humira’s original patent expired in December 2016. The settlements ended …
AbbVieAmgenSamsung BioepisMylanBoehringer Ingelheim+3 morepharmaceutical-industrypatent-abusedrug-pricinghealthcareevergreening+2 more
Walgreens formally terminates its partnership with Theranos after discovering that 31,000 Walgreens customers had received voided test results from the blood-testing company’s faulty devices. The termination follows months of deteriorating relations after the October 2015 Wall Street Journal …
WalgreensTheranosElizabeth HolmesFDACMScorruptionfraudregulatory-capturetechhealthcare+3 more
Johns Hopkins researchers published findings demonstrating that pharmaceutical companies were systematically gaming the 1983 Orphan Drug Act by obtaining orphan drug designations—intended for treatments of rare diseases affecting fewer than 200,000 Americans—for blockbuster drugs generating billions …
Johns Hopkins UniversityFDAAbbVieRocheJohnson & Johnson+4 morepharmaceutical-industryregulatory-capturetax-avoidancedrug-pricinghealthcare+2 more
Wall Street Journal reporter John Carreyrou publishes the first investigative article exposing Theranos’ fraudulent blood-testing technology, revealing that the company was using traditional blood testing machines instead of its proprietary ‘Edison’ devices and that test results …
John CarreyrouElizabeth HolmesTheranosWall Street JournalWalgreens+1 morecorruptionfraudregulatory-capturetechhealthcare+3 more
The Centers for Disease Control and Prevention began investigating a multistate fungal meningitis outbreak in September 2012 that ultimately killed 64 people and sickened 798 individuals across multiple states who received contaminated methylprednisolone steroid injections from the New England …
New England Compounding CenterBarry CaddenFDAMassachusetts Board of PharmacyCDC+1 morepharmaceutical-industryregulatory-capturefdahealthcarepublic-health+1 more
Jeffrey Siegel, an FDA staff member specializing in arthritis drug reviews, oversaw the 2010 approval of Genentech tocilizumab (Actemra) for arthritis treatment. Within months of the approval, Siegel left the FDA to join Genentech and its parent company Roche as director of the division that …
On April 5, 2010, the FDA approved Purdue Pharma’s reformulated OxyContin designed to make it more difficult to crush, snort, or inject—14 years after the original drug’s launch and three years after the company’s guilty plea to criminal misbranding. Purdue ceased shipping the old …
FDA epidemiologist Dr. David Graham delivered explosive testimony before the U.S. Senate Finance Committee, declaring that ’the FDA, as currently configured, is incapable of protecting America against another Vioxx. We are virtually defenseless.’ Graham revealed that his study showed …
Dr. David GrahamFDAMerckU.S. Senate Finance CommitteeGovernment Accountability Projectregulatory-capturefdapharmaceuticalswhistleblowervioxx+2 more
The FDA approved Purdue Pharma’s OxyContin application, including a scientifically unsubstantiated claim that delayed absorption ‘is believed to reduce the abuse liability of a drug.’ This approval occurred without clinical trials to prove the safety claim and marked the beginning …
FDAPurdue PharmaDr. Curtis WrightSackler Familyregulatory-capturefdapharmaceuticalsopioid-crisisrevolving-door+1 more
On October 10, 1962, President John F. Kennedy signed the Kefauver-Harris Amendment to the Federal Food, Drug, and Cosmetic Act, fundamentally transforming pharmaceutical regulation in the United States. The legislation, driven by the thalidomide disaster in Europe, required drug manufacturers to …
Senator Estes KefauverRepresentative Oren HarrisPresident John F. KennedyFrances KelseyRichardson-Merrell+1 moreregulatory-reformpharmaceutical-industrypublic-healthcorporate-lobbyingfda