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  • Regulatory NewsRegulatory News

    Sanofi and J&J Lead the Way With Clinical Trial Transparency, Study Finds

    Clinical trial transparency among large pharmaceutical companies is high, although opportunities for improvement remain, according to a study published Tuesday in the BMJ. Researchers from New York University, Yale, Stanford and the International AIDS Vaccine Initiative reviewed data from more than 45 sources on 505 trials for 14 drugs approved by the US Food and Drug Administration (FDA) in 2014. "On the drug level, about half of FDA-approved drugs have publicly ...
  • Regulatory NewsRegulatory News

    Senate to Take on Pharmaceutical Prices Again: Real Reform or More of the Same?

    The Senate Health, Education, Labor & Pensions (HELP) committee will hold a hearing Tuesday on prescription drug costs and look to address a problem many in America are grappling with: how the drug delivery system affects what patients pay. The hearing will likely address how pharmacy benefit managers (PBMs), insurers and others in the prescription drug ecosystem impact prices and what can be done to bring them down, though some are questioning whether anything subs...
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    FDA Explains Why Newly Approved Biologic’s Name Lacks a Suffix

    The US Food and Drug Administration (FDA) approved a new biologic this week, but its name did not adhere to recently finalized guidance calling for all new and previously approved biologics and biosimilars to have a four-letter random suffix attached to their nonproprietary names. “This week’s biologic, [ Valeant Pharmaceuticals ’] Siliq (brodalumab) was licensed under section 351(a) of the Public Health Service Act , and thus is within the scope of our recently ...
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    Senators Look to Halt Price Spikes of Off-Patent Drugs

    Sens. Susan Collins (R-ME) and Claire McCaskill (D-MO) on Wednesday released a 131-page report explaining the details behind specific price increases for off-patent drugs and ways Congress can combat such spikes. The report offers a long look at the Senate Special Committee on Aging’s investigation from 2016 into the price increases of a number of targeted and acquired drugs from four companies including, Turing Pharmaceuticals , Valeant Pharmaceuticals , Retrophin I...
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    FDA Warns Valeant Over Quality System Violations

    In a letter dated 3 November and released Tuesday, the US Food and Drug Administration (FDA) warned Valeant Pharmaceuticals over quality system violations. The warning letter comes as an inspection of the company’s Rochester, NY, site on 23 August 2016 through 1 September 2016 found Valeant’s “SPAG-2” and “ONSET Mixing Pen” devices are adulterated because design validation activities were not documented or performed. In addition, FDA said corrective and preventive ac...
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    Developing the Next Female Viagra? FDA Offers Draft Guidance With Caveats

    The controversial US Food and Drug Administration (FDA) approval last year of the first drug intended to treat women bothered by a lower sex drive has opened the door for other companies to develop similar drugs. Now, FDA is trying to clarify what these drug developers racing to create the next female Viagra should focus on, with particular discussion of the challenges involved, including diagnostic criteria, endpoints and patient-reported outcome (PRO) instruments. Th...
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    FDA Hits Valeant’s Bausch & Lomb With Form 483

    The US Food and Drug Administration (FDA) on Tuesday released a Form 483 for Valeant’s Bausch & Lomb sterile drug manufacturing facility in Tampa, FL, citing the site for microbiological contamination of drugs purporting to be sterile. The eight-day inspection last February uncovered four observations detailing : Written records of investigations into unexplained discrepancies do not include the conclusions and follow-up Procedures designed to prevent microbiological...
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    Senate Committee Offers Inside Look at the Rise and Fall of Valeant Pharmaceuticals

    The 800 pages of internal emails, correspondence and drug pricing statistics released by the Senate Special Committee on Aging over the weekend offers an inside look at how the multibillion-dollar Valeant Pharmaceuticals with 22,000+ employees jacked up the prices of a number of drugs, by as much as 6,000%, and then lamented the subsequent media and investor questions. The document dump by the committee comes almost two weeks since the company’s former CEO, J. Michael Pe...
  • Regulatory NewsRegulatory News

    Arbitrary Pharmaceutical Price Gouging: Valeant Defends its Business Model

    As the anger over Martin Shkreli’s infamously steep and entirely arbitrary price hike of a rare disease drug has subsided, Congress has begun to turn its attention to other companies, such as Valeant Pharmaceuticals, which rely on price gouging as a foundation of their business models. On Wednesday, the Senate’s Special Committee on Aging grilled not only Valeant’s outgoing CEO, J. Michael Pearson, but its former chief financial officer, Howard Schiller, and one of the c...
  • Regulatory NewsRegulatory News

    Updated: Governor Takes Issue With Super Bowl Drug Ad as New House Bill Looks to Restrict DTC Pharma Advertising

    [Editor's note: This story was updated with new details on the text of the DeLauro bill to restrict DTC pharma advertising and new details on a letter from AstraZeneca to Gov. Shumlin]. Vermont Gov. Peter Shumlin (D) has sent a letter to pharmaceutical companies AstraZeneca and Daiichi Sankyo calling on them to pull their advertisement that aired during the Super Bowl. The ad promoted a drug to treat opioid-induced constipation. “Like many Americans, I was baffled by th...
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    House Hearing Focuses on Harm Done by Drug Price Spikes

    The highly anticipated House Oversight Committee hearing on Thursday was not without its fireworks, though beyond the airing of a lot of discontent, few new options for halting drug price increases were brought to the table. About an hour into the hearing, Martin Shkreli, former CEO of Turing Pharmaceuticals, who previously called the increase in price of a toxoplasmosis drug a “very handsome investment,” was escorted out after he used his Fifth Amendment rights to avo...
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    Arizona Supreme Court Ruling Realigns State With Others on Drugmakers’ Warning Labels, Lawyer Says

    An Arizona Supreme Court ruling last week brought the state in line with a number of other states in terms of its use of the “learned intermediary doctrine,” under which drug manufacturers satisfy their duty to warn consumers about their products by giving appropriate warnings to a prescribing physician or other health care provider. The case under review, known as Watts v. Medicis Pharmaceutical Corporation, pitted Amanda Watts, who developed lupus and hepatitis after t...