Forgot password?
Sign up today and your first download is free.

FDA Week - 03/16/2018

  • FDA Publishes Proposal To Set Maximum Nicotine Standard For Cigarettes

    FDA released Thursday (March 15) its much-anticipated advance notice of proposed rulemaking seeking public input on a standard level of nicotine for combustible cigarettes. In its ANPRM, the agency points to research that suggests levels of .3, .4 or .5 milligrams of nicotine per rod would lead to cigarettes being minimally or non-addictive.

    1408 words

  • House Right To Try Bill Wouldn't Preempt State Laws' Insurance Limits

    Should House lawmakers' updated federal Right to Try bill eventually be passed through Congress and signed into law, provisions in state laws that some have called anti-patient, like those allowing insurers to deny coverage to those using Right to Try drugs, would not be preempted by the federal law, legal experts tell Inside Health Policy. Moreover, manufacturers and doctors would gain greater protection against injury suits, which Public Citizen has argued would "eliminate a strong incentive for manufacturers and health care providers to act responsibly and in the best interests of patients," but others say the shield is meant to assuage one of the biggest concerns preventing companies from providing unapproved drugs.

    1688 words

  • FDA Counsel, DOJ Promise Off-Label Enforcement Based On Risk, Harm

    FDA Chief Counsel Becky Wood's recent remarks that FDA is taking a "risk-based approach" toward warning letters, focusing on "significant public health risks, rather than overly technical or insignificant violations," left one industry attorney pleased, pharma critics frustrated and some policy watchers waiting for more details before predicting how the Trump FDA will deal with off-label promotion. Wood's remarks came just days after a deputy assistant attorney general also underscored that the Department of Justice will go after off-label cases that result in patient harm, rather than pursuing "technical regulatory violations."

    1957 words

  • Former USDAer: Past Bodes Ill For Tackling Overlapping FDA, USDA Turf

    If prior efforts are any indication, the latest federal government bid to eliminate overlapping food safety roles played by FDA and the U.S. Department of Agriculture is likely to fail, a former USDA food safety chief told Inside Health Policy.

    1809 words

  • Gottlieb: 'Enormous Investment' Needed For New Flu Vaccine Technology

    A fundamental change in manufacturing would be needed for the United States to shift from "antiquated" egg-based flu vaccines to newer technologies like cell-based vaccines and recombinant DNA technology, which could pave the way toward a universal vaccine, government experts told lawmakers March 8. But investing in continuous manufacturing can help usher along this shift, FDA Commissioner Scott Gottlieb argued.

    1230 words

  • E&C To Discuss Bills That Expand, Clarify FDA's Opioid Authorities

    The House Energy & Commerce health subcommittee announced on Wednesday (March 14) the slate of 21 bills it intends to discuss during its two-day hearing on legislation that could help stem the opioid crisis. Six of the bills enhance and clarify FDA's ability to, among other things: mandate post-market studies; use accelerated approval programs to expedite new pain therapies and addiction treatments; increase its effectiveness in the international mail facilities; and consider misuse and abuse as part of the drug review and approval process.

    434 words

  • FDA Warns Duodenoscope Manufacturers Over Postmarket Requirements

    FDA issued warning letters to duodenoscope manufacturers Olympus, Fujifilm and Pentax for failing to comply with postmarket surveillance requirements that would help determine whether health care facilities were able to properly clean and disinfect the companies' devices, the agency announced on Friday (March 9). While all three companies tell Inside Health Policy they intend to work with FDA to resolve the issue, one noted that the infections associated with the scopes -- which originally prompted the study requirement -- have gone down.

    1215 words

  • FDA To Meet With Substance-Use Disorder Patients On Opioid Treatments

    FDA will hold a meeting in April to garner patients' perspectives on the effects of and potential treatments for opioid use disorder (OUD), the agency announced Tuesday (March 13). The agency will focus on the symptoms and daily impacts of OUD that matter most to patients and patients' perspectives on current treatment approaches.

    319 words

  • Pallone Introduces Bill To Boost HHS, FDA Imported Drugs Seizure Authority

    House Energy & Commerce ranking Democrat Frank Pallone (NJ) introduced legislation Tuesday (March 13) that would grant HHS and FDA more authority to refuse admission of controlled substances or other drugs into the United States, if the agencies deem they pose a health risk or are counterfeit. The bill would also set up a $10 million account to support FDA in its surveillance and screening of imported drugs, including ramping up staff at international mail facilities (IMFs).

    1197 words

  • Advocates Camp Outside Gottlieb's Home, Demand Electroshock Ban

    Several dozen protesters with the disability advocacy group ADAPT have camped outside of the condominium of FDA commissioner Scott Gottlieb since Friday, March 9, demanding the commissioner finalize a regulation, proposed in 2016, that would ban the use of electric shock devices to modify behavior in people with disabilities.

    547 words

  • FDA, Industry Makes Pitch For Animal User Fee Bill At E&C Hearing

    Like their colleagues in the Senate did last month, members of the House Energy & Commerce health subcommittee considered Wednesday (March 14) draft language to reauthorize the Animal Drug User Fee Agreement (ADUFA) and the Animal Generic Drug User Fee Agreement (AGDUFA).

    652 words

  • Former Obama Official Warns Of Security Risks As Health Sector Automates

    The former director of the Obama administration's cybersecurity commission is cautioning the health industry about moving too quickly to data-driven innovations and automation without adequate security consideration, advice that comes as the industry faces increased ransomware and other denial of service attacks.

    815 words

  • Two Governors Say More Federal Funding Needed To Fight Opioid Crisis

    The governors of Maryland and Oregon told members of the Senate health committee Thursday (March 8) that more federal money, beyond the $6 billion that Congress authorized last month, would allow states to better fight the opioid crisis.

    307 words

  • Pew: Eliminating Protected Drug Classes Might Not Save Much Money

    Pew Charitable Trusts reports that rescinding protected drug classes likely would not save that much money because generic competition is strong in those drug classes, plans already can restrict coverage using other tools and Medicare requirements that are separate from protected class status might prevent plans from excluding drugs anyway.

    432 words

  • Brands' Share Of Part D Donut-Hole Costs Could Be Lowered

    Brand drug lobbyists say there is a decent chance Congress will lower drug companies' share of Medicare Part D donut-hole costs by 5 percent to 6 percent as lawmakers could provide that much relief without increasing the deficit due to an updated estimate by the Congressional Budget Office, though drug makers are unlikely to get more than that because lawmakers don't want to negotiate offsets. Industry's goal is to use appropriations legislation to dial back the drug industry's share of coverage-gap costs, but that bill is supposed to be passed by Friday, and there has been little-to-no discussion yet between the parties on offsets.

    503 words

  • Trump's Advisory Board Suggests NAS Panel Lead Rx Value-Based Efforts

    The National Academies of Sciences, Engineering, and Medicine should convene a committee to review schemes for determining the value of cancer drugs, a presidential cancer advisory panel recommended Tuesday (March 13). The Institute for Clinical and Economic Review (ICER) and the Memorial Sloan Kettering Drug Pricing Lab have value frameworks, but drug makers often push back against those approaches and there is no broadly accepted approach to determining the value of drugs.

    309 words

  • Academics: Change 340B Bills To Better Account For Safety Net Services

    Academics who have backed changing the 340B program are calling for tweaks to 340B-overhaul bills, the 340B PAUSE and 340B HELP Acts, to better account for safety-net services. Hospitals and Ryan White clinics have raised concerns about the bills' focus on charity care, and 340B Health released an updated report Tuesday (March 13) that says data suggests 340B hospitals treat more low-income patients and provide more uncompensated care than others not in the program.

    627 words

  • AHIP Taps CEO From Within Its Own Ranks Who Has Criticized Drug Prices

    America's Health Insurance Plans has chosen its chief operating officer, Matt Eyles, as the group's new president and CEO, the trade group announced Wednesday (March 14). Eyles criticized drug makers' high list prices in recent testimony on Capitol Hill.

    180 words

  • New Right To Try Bill Doesn't Win Over Patient Advocates

    House Energy & Commerce Committee Republicans' attempts to craft a Right to Try bill that patient advocates can support failed, with major groups refusing to back anything that cuts FDA out of the process. While the new bill did appear to answer many of the concerns laid out by FDA Commissioner Scott Gottlieb by narrowing the patient population covered and revising the informed consent process, the bill failed to garner the support of Democrats necessary to clear the House.

    1751 words

  • FDA, Compounder Reach Temporary Agreement, Firm Gets New Inspection

    503B compounder Cantrell Drug Company and FDA have reached a temporary agreement to reinspect the facility after FDA moved to force the company to shut down and the compounder filed a subsequent restraining order against the government, according to a new document filed in the case on Friday (March 9).

    281 words

  • Rules Committee To Take Up Right To Try Monday

    The House Rules Committee will hold a hearing Monday (March 19) on the Right to Try bill that failed to pass the House under suspension of the rules last week, the committee announced Thursday (March 15). The move was expected given the bill sponsor pledged immediately after the failed vote to have the Rules Committee take up the bill, with a goal of eventually bringing up the measure for another floor vote under regular order.

    153 words

  • Right To Try Vote In House Fails After GOP Tries To Bypass Regular Order

    After a fiery partisan debate, the House failed to pass under suspension of the rules the revised Right to Try legislation Energy & Commerce Committee leaders unveiled this weekend. The final vote tally, 259-140, was not enough to secure the two-thirds majority needed to pass a bill under suspension, but a sponsor of the bill indicates he will push for another vote under regular order, and it appears he has the support of GOP leadership.

    895 words