D

ear President Trump,

During your speech to Congress last week, you took a whack at the Food and Drug Administration for its “slow and burdensome” approach toward approving medicines. You then suggested that if “we slash the restraints” on the agency, Americans will be blessed with more miracle cures.

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  • Why isn’t sodium citrate 4% (4% Sodium citrate anticoagulant USP) approved in the US as a lock flush solution to replace heparin? Sodium citrate 1.8 gm is in every unit of blood as an anticoagulant. It is used as a pH buffer in injectable products as an excipient. The FDA’s position is that sodium citrate as a lock flush solution needs to be approved as an NDA, then a PMA as a device. Is this the “least burdensome regulatory path”? How is risk benefit being applied compared to exposure to heparin? Just one example of FDA over regulation of a product that could benefit society. The sodium citrate 4% is approved for use in Canada and Europe as a device.

    • Actually “Hep lock” is a term of art. It hasn’t been used in flush solutions for years. It has been replaced by saline, plentiful, safe and cheap.

  • Ed, I agree with the points in your article. However it is only one half the story. The other half, which could speed things up is unwinding the increasingly burdensome regulations governing design and conduct of clinical trials. The “Bible” here is 21CFR12. Drugs for Human Use. Linked below is just one of the many newly bloated regs, on responsibilities of investigators (Form 1572). Now the FDA wants to know everything about any potential financial conflicts of interest by investigators. We have to hand hold a lot of investigators who think that if they own one share of some XYZ drug company in some ABC mutual fund then they must disqualify themselves.

    Just one example.

    http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=312.53

  • Ed, you actually seem a bit misguided. The FDA is a bloated, unelected, unaccountable group of federal leeches. I look forward to seeing significant downsizing of the administrative state. Thank you for opinion though.

  • Excellent commentary. I worked on the analytics for Myozyme, the Pompe’s drug that was approved so had a good view of that product coming to the market. I would rather see more people hired into the FDA and pay them better to attract very high quality talent to improve the entire process.

  • A lot of patient pressure on the FDA dates back to Pres. Obama’s 1st term. An FDA buoyed by a ” Big Govt. can fix all your problems mentality ” . More interested in ” Flexing It’s Regulatory Muscle with Big Pharma “, ( from the WSJ , 2011 ), than in saving patient lives . Delaying approval for drugs that cured end stage cancers – like Kadcyla and Iclusig . Patient activists fighting for the ” Right To Try ” exposed an FDA that delayed all compassionate use requests with hours and hours of bureaucratic paperwork . Pro – FDA writers always cite the ” months ” that the FDA takes to approve – that is only the end of a long, 20th century trial system- 7 to 10 years long, marked by companies fearing the FDA regulatory muscle – that can nitpick and delay approval for years – bankrupting companies , costing execs their jobs like the CEO of Ariad .
    The President is a shoot from the hip , a thin- skinned ” tweety ” type – but with FDA and the slow drug approval system – he is right – it needs a thorough over haul .
    Another note – comparing the FDA and European regulators is like comparing Slow with Slower . Big Govt. Bureaucracy over there is stifling innovation – few, if any , new drugs coming out of the UK and Europe.

    • Attract high quality people by paying more and hire more people to help speed the process. The FDA budget has been cut for years. Given the tons of data input for approval that must be reviewed, more people are needed. OR maybe have clinical trials require new drugs be compared to best current treatment instead of a placebo–would cut down on the number of approvals and me-too drugs that are not that efficacious.

  • The use of ‘burdensome’ in the closing paragraph is certainly a deft turn of phrase. One could think of more barbed phases that would indeed be appropriate but in deference to the office, the term used will serve. That said, do be aware of your surroundings, Mr Ed.

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