Posted by: Audrey Erbes | February 5, 2017

Potential Setback of Drug Protection a Hundred Years

Trump Administration Shoots from Hip Without Knowledge of Industry

Donald Trump once again demonstrates he and his inner circle advisors are ignorant of the U.S. Drug Industry and its history and progress. He continues to spout sound bites from his campaign without understanding his hasty actions to reform the FDA and appoint an inexperienced new commissioner are likely to produce a major setback in the progress of the agency which with 8 years of steady professional leadership has made major advancements. Under the George W. Bush Administration there were gaps in leadership of the agency, examples of politicization of the agency that tarnished its reputation and slowed down approvals. We know that this agency needs capable person with science/medical background at the helm and then longevity in holding the office.

Examples of Trump’s nonsensical  sound bites coming out of last week’s meeting with pharmaceutical executives include: Promise to cut regulations “at a level that nobody’s ever seen before” to establish “a quick process” for approving new products, while still providing “tremendous protection for the people.” Such statements are ignorant of the facts that industry has worked closely with FDA to accelerate new drug approvals, which now have been reduced to only 10 months on average and with major decrease in time for breakthrough and priority therapies. Whenever he mentions cutting regulations, remember this is code for taking away necessary protections for our people and giving industry free rein to accumulate more profits.

The Pharma industry recognizes the benefit of an efficient, rigorous FDA regulatory system that approves therapies that demonstrate a certain level of safety and efficacy to gain acceptance from clinicians, patients, and payers that set coverage and reimbursement levels commensurate with value. This costly and complex vetting process is not a hindrance but rather sets a highly prized “gold standard” that facilitates market approval around the world. This high bar for FDA approval enhances market position for U.S. companies’ drugs and bolsters exclusivity and protects patents around the world.

The FDA has already speeded up its approval process for generic drugs, largely due to a user fee program adopted five years ago. See new administration’s acts that will put the agency’s effectiveness in jeopardy.

(Does pharma Really Want to Overhaul FDA? Feb 01, 2017 by Jill Wechsler, at

Harry Wachob, Founder and President of the Bio2Device Group has summarized some the relevant highlights in talk Jan. 31:

  • The White House freezing all new and pending federal regulations forced the Department of Health and Human Services to withdraw a dozen rules, including one that could delay eligibility for those with exchange plans, Medicare Part D or Medicaid.
  • The latest addition to Trump’s possible FDA commissioners is Joseph Gulfo, an outspoken critic of the agency who has penned a manifesto for its reform. “Dr. Joseph Gulfo is an advocate of approving drugs based on safety and surrogate efficacy data.”
  • FDA Cites 22 case studies of different drugs, vaccines and devices that failed trials, making the case for the Phase III as the Gold Standard.
  • Regulators in North America and Europe evaluate safety before human trials can proceed, they do not currently demand meaningful evidence for potential efficacy, writes McGill bioethicist Jonathan Kimmelman. “We believe that many (first-in-human) studies are launched on the basis of flimsy, under-scrutinized evidence.“
  • Require drug sponsors to include negative results from animal studies in documents submitted to investigators and ethics committees.
  • Allow trials to proceed only after careful vetting of the preclinical evidence by independent experts.
  • Encourage reviewers to consider a broad base of evidence in assessing the probability that a drug will prove clinically useful: for example, how have other drugs in the same class performed in trials?
  • President Donald Trump’s move to instate a federal hiring freeze quickly set off concerns in the pharmaceutical industry as experts said a handcuffed FDA (500+ jobs frozen) might not be able to keep up with an influx of drug applications.
  • The FDA is set to receive 1,600 abbreviated new drug applications this fiscal year. Already, the generics industry, which counts on strong FDA staffing to green light cheap alternatives to branded drugs, has voiced its concerns.
  • In total, there are 4,000 generic applications pending at the FDA, according to GPhA, and 850 open positions at the agency’s CDER. Among that group are 150 openings for generic drug reviewers.

Trump ‘s requirement that 2 regulations must be cut out for every new regulation approved doesn’t fit the life science industry and will set the FDA back 100 years.

Highlights of Bay Area Life Science Meetings Week of Feb. 5, 2017

  • Stanford University Innovator’s Workbench Speaker’s Series, hosted by the Byers Center for Biodesign at Stanford University, Monday Evening, Feb. 6, 2017; Speakers: Michael “Mick” Farrell, CEO of ResMed and Peter Farrell, Founder & Executive Chairman of ResMed, Interviewer: David Cassak
  • Bio2Device Group, Tuesday Morning, Feb. 7, 2017, Topic: “New Breakthrough Technology- Quoros -Taming the Microbial World,” Speaker: Manuel Serrano, VP of Formulation Development, LiveLeaf
  • JLABS, Wednesday Early Evening, Feb. 8, 2017, Topic: ”She Started It: A Film Screening,” Speakers: Moira Gunn | Assistant Professor, Business Analytics and Information Systems, University of San Francisco, Laura Shawver | CEO, Cleave Biosciences,Moderator: Jim Viola | Innovation Activation Specialist, Johnson & Johnson
  • AWIS Journal Club, Wedesday Evening, Feb. 8, 2017, Event: Journal Club
  • WIB, Thursday Morning, Feb. 9, 2017, Event: “WIB-National Webinar “Class II Medical Device Innovation and IP Strategy: Case Study in Women’s Health Products,” Speaker: Debra Kurtz, President, Kurtz Consulting Inc

You can download the details for the upcoming events this week and those through April 2017 with audreys-picks-feb-5-2017.




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