• Regulatory NewsRegulatory News

    Biden’s day one regulatory freeze

    Newly inaugurated President Joe Biden wasted little time in acting to halt former President Donald Trump’s “midnight regulations” and to revoke some of his predecessor’s controversial deregulatory orders in his first day in office.   Biden’s “regulatory freeze” memorandum will likely impact several moves by the Department of Health and Human Services (HHS) in the final days and weeks of the Trump administration that impact the US Food and Drug Administration (FDA), e...
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    House Bill Aims to Cut Insulin List Prices to 2006 Levels

    As patients who need insulin to live continue to struggle to obtain the increasingly costly injections, Rep. Diana DeGette (D-CO) introduced a bill this week to lower insulin list prices to 2006 levels. The shift to 2006, according to DeGette, would lower the average list price for a vial of insulin from about $300 to approximately $68. A report released Thursday by the White House explains how in recent years the list price of insulin has increased dramatically, w...
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    Republicans Rebuke Pelosi Drug Pricing Bill

    United behind the pharmaceutical industry’s criticism of a wide-ranging drug pricing bill from House Speaker Nancy Pelosi (D-CA), Republicans on the subcommittee on health of the House Committee on Energy & Commerce on Wednesday criticized the bill at length and referred to the negotiation provisions as price controls. Chairwoman Anna Eshoo (D-CA), however, countered that the bill, known as HR 3 , includes many provisions that President Donald Trump and other Republica...
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    House E&C Offers Recommendations to Improve 340B Drug Pricing Program

    The House Energy & Commerce (E&C) Committee on Wednesday released an 80-page report outlining issues and recommendations to improve the 340B drug pricing program, which helps reduce the prices of certain drugs for participating hospitals, health centers and other entities that provide care for vulnerable patients. The 80-page report follows an October House E&C hearing in which hospital executives pushed back on the idea that the 340B program should be narrowed o...
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    Updated: House and Senate Pass Tax Overhaul

    The US House of Representatives and the Senate on Wednesday passed the GOP tax overhaul bill. President Donald Trump indicated he will sign the bill into a law. Bill Details Members of the House-Senate Conference Committee on Friday released the final text of the bill, which would reduce the rare disease research tax credits biopharma companies can claim by half . The cut would reduce the credits claimed by companies by $32.5 billion from 2018 to 2027, according t...
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    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 ...
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    Apple, Verily and J&J Among 9 Selected for FDA Digital Health Pilot

    US Food and Drug Administration Commissioner Scott Gottlieb took the stage Tuesday at AdvaMed’s MedTech conference in San Jose, California, unveiling the nine companies selected among 103 applicants to participate in the agency’s precertification pilot for digital health applications. FDA  launched the pre-cert pilot  in July as part of the agency’s  Digital Health Innovation Action Plan. The pilot participants, representing a range of companies and technology in the ...
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    MedTech Industry Sees Challenges in Restarting Operations, Helping Puerto Rico

    With more than three million Americans in Puerto Rico facing no electricity because of Hurricane Maria, medical device and biopharmaceutical companies, many of which have manufacturing facilities on the island, are doing what they can to work with the US government to help their employees and restart operations. A spokesman from MedTech industry group AdvaMed told Focus at the group’s MedTech conference in San Jose, California on Monday that the group is working w...
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    Congress Sets Sights on Pharma Cybersecurity After Attack

    Leadership from the House Energy and Commerce (E&C) committee on Wednesday called on Merck CEO Ken Frazier and Department of Health and Human Services Secretary (HHS) Tom Price to brief Congress on the impact of a recent cyberattack on the healthcare sector. Background On 27 June, a cyberattack involving ransomware known as "Petya" or "NotPetya" infected government and business computer systems in Ukraine before spreading to other corporate networks around the world. M...
  • Feature ArticlesFeature Articles

    Medical Technology: Connecting Reimbursement and Regulatory for US Medical Devices

    This article discusses some basic US reimbursement concepts in the context of the regulatory function and the interplay of the two within the broader business strategy. Introduction Bringing new and innovative medical technologies to the US market has numerous challenges, including market identification, product development, regulatory and quality requirements, and demonstrating both clinical and economic effectiveness. In recent years, adequate reimbursement has beco...
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    White House Commission on Opioids to Trump: Declare a National Emergency

    The White House Commission on Combating Drug Addiction and the Opioid Crisis on Monday urged President Donald Trump to declare the opioid crisis a national emergency under the either the Public Health Service Act or the Stafford Act . In an interim report released Monday afternoon, the commission, chaired by New Jersey Gov. Chris Christie (R),  laid out eight specific actions ahead of a final report to be issued sometime in the future, which will include "a f...
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    White House Doubles Down on Call to Fund FDA Entirely With Industry Fees

    Following the House of Represenatatives' passage of the bill to reauthorize US Food and Drug Administration (FDA) user fees on Wednesday, the White House doubled down on its earlier call to amend the agreements so that FDA is entirely funded by medical products industries. "The Administration urges the Congress to provide for 100 percent user fee funding within the reauthorized programs," the White House said in a statement . "In an era of renewed fiscal restraint,...