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FDA Week - 08/18/2017

  • FDA Backs Industry Preemption Argument In NYC Menu Labeling Lawsuit

    Answering the calls of congressional Republicans, FDA is siding with the food industry in a lawsuit seeking to stop New York City's menu labeling regulation from being enforced until FDA implements its national standard. In a statement of interest filed Monday (Aug. 14), FDA along with HHS and the U.S. attorney's office argue that the city's attempt to begin enforcement of menu labeling requirements nine months before the federal standard is set to go into effect should be blocked by the court.

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  • FDA To Assess Maximum Nicotine Level, Benefits and Risks Of E-Cigs

    In a newly published New England Journal of Medicine article, FDA Commissioner Scott Gottlieb expanded on how FDA will move forward with establishing a regulatory framework to lower nicotine levels in combustible cigarettes, including considering peer-reviewed studies to determine a maximum nicotine level, looking into how lowering nicotine will affect current smokers' behavior and investigating the potential for smokers to turn to alternative tobacco products.

    773 words

  • Biosimilar Experts: No Scientific Rationale For Requiring Bridging Studies

    In a newly published paper, two biosimilar experts make a scientific case for abandoning requirements that biosimilar sponsors conduct bridging studies between foreign biologics and U.S. licensed reference products before using non-U.S. samples for the testing required for approval. The experts contend that bridging studies have been required solely out of precaution and cost developers at least several hundred thousand dollars. They add that subjecting human subjects to those trials could potentially be unethical.

    1490 words

  • Industry/Patient Alliance Says REMS Bills Raise Liability, Diversion Concerns

    Concerns over Risk Evaluation and Mitigation Strategies (REMS) abuse are largely misinformed and current reform proposals would create liability and diversion concerns for brand drug makers, an alliance of pharmaceutical companies and patient advocacy organizations argues in recent comments to FDA. But a generic drug source argues that the criticisms by the coalition, the AIMED Alliance, are false and should be dismissed if "we trust the FDA to do their job."

    2381 words

  • White House Reviews Plan To Extend Agricultural Water Compliance Dates

    The White House is reviewing an FDA plan to extend the compliance date for the Food Safety Modernization Act's agricultural water requirements for produce, an action the agency has said would provide time to address stakeholder concerns that some of the requirements are difficult to implement. The White House Office of Information and Regulatory Affairs received the proposed rule from FDA Friday (Aug. 11), months after the agency first announced it would take action to craft a workable rule that firms could comply with at a high rate.

    552 words

  • Trump Criticizes Rx Prices After Merck CEO Resigns From WH Council

    President Donald Trump used Merck CEO Kenneth Frazier's resignation from the White House manufacturing council on Monday (Aug. 14) as an opportunity to lash out at the pharmaceutical industry over high drug prices -- though Public Citizen blamed Trump for being "all talk, no action" when it comes to lowering those costs.

    334 words

  • OMB To Review Soy Protein Health Claim Change

    The White House Office of Management and Budget is reviewing an FDA proposed rule, first planned by the Obama administration, to change the health claims that can be made about soy protein and its effect on coronary heart disease. The unified agenda's description of the rule, which was updated last month, says the agency has found that the science supporting that claim isn't sufficient to meet the standards needed for an authorized health claim. However, the description of the rule says there is some evidence supporting a benefit from soy protein, which may result in a proposal for a qualified health claim instead of an authorized health claim.

    460 words

  • Consumer Groups Locked In Legal Battle With FDA Over Formaldehyde

    After receiving an unsatisfactory response to a citizen petition calling for FDA action on formaldehyde in keratin hair straighteners, two environmental groups are suing FDA in an attempt to force the agency to make a decision, within a set time period, on whether to ban the ingredient. The agency has pushed for the case to be dismissed, arguing that a lawsuit cannot be filed to force an agency to take a particular action in response to a citizen petition, and that the groups cannot sue solely on behalf of the general public at large.

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  • Lawmakers Pull FTC In Opposing Directions On Contact Lens Rule

    Two bipartisan groups of lawmakers are pulling the Federal Trade Commission in opposite directions on its plan to finalize a controversial rule on contact lenses that would require patients sign a document confirming they received their prescription following an exam. The pressure from Capitol Hill comes as both conservative and liberal advocacy groups attempt to sound the alarm on reported attempts by the optometrist lobby to get lawmakers to quash the requirement.

    1046 words

  • Bill Would Hike Medical Device Cyber Risk Transparency, ICS-CERT Role

    A recently introduced Senate cybersecurity bill would expand the responsibilities of the Industrial Control Systems Cyber Emergency Response Team (ICS-CERT) to investigate connected medical devices' cybersecurity vulnerabilities and coordinate responses to cyber incidents. The bill would also mandate that manufacturers provide cybersecurity fixes and updates free of charge and obtain permission to remotely access a device after selling or transferring ownership, and would require agencies that work in the cyber space to develop a report card indicating the functions of cyber devices.

    861 words

  • Experts Worry Tax On Opioid Manufacturers Would Raise Health Care Costs

    Experts expressed skepticism about whether a legislative proposal to slap a federal excise tax or fee on opioid manufacturers would help patients as intended, saying the fee would more than likely raise the cost of drugs for consumers who need pain medication. However, a proponent of the bill at the state level likens the tax to what has already been implemented in other industries, including tobacco and alcohol, and says the pharmaceutical companies should be held accountable to help those who have been hit hardest by the opioid epidemic.

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  • Patient Group Seeks 'Fair' Price For First-Of-Its-Kind Cancer Therapy

    In anticipation of what could be the most expensive cancer drug to date, the Patients for Affordable Drugs launched Thursday (Aug. 17) a national campaign demanding that Novartis factor in the considerable taxpayer investment in early research of the company's CAR-T cell therapy, which is at the forefront of individually tailored medicines that could cure certain cancers. The patient advocate group suggests the company limit the price in the United States to a level similar to prices in other wealthy nations or accept the price established by an independent organization, such as the Institute for Clinical Economic Review.

    413 words

  • Industry Coalition Backs HHS' Cyber-Threat Info-Sharing Group

    A coalition of critical industry groups and technology companies is defending HHS' recent decision to establish a cyber-threat information sharing center, arguing the group would augment rather than duplicate info-sharing efforts by the Department of Homeland Security.

    631 words

  • FDA Guidance Lays Out Deeming Rule Extension Deadlines

    FDA issued guidance that stretches out the deadlines for certain tobacco deeming rule pre-market review compliance requirements. The extension applies to pre-market review of newly regulated tobacco products on the market as of Aug. 8, 2016, including electronic nicotine delivery systems (ENDS), hookah, pipe tobacco and cigars.

    378 words