Pharmaceutical companies are constantly creating new drugs and medical devices to address the countless problems that can arise in the human body. Is only makes sense that we quickly bring these solutions to market to help those who are sick or injured, right? Well, not so fast.

The FDA wants to shorten the 510(k) process which already fast-tracks products with bad results. Will cutting the time period cause more patient health problems?
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Many times drugs and medical devices have caused horrible adverse effects that are often worse than the original condition they were supposed to treat. One part of the problem is the FDA’s 501(k) process that approves new products if they have a vague resemblance to a previously approved drug or device. Now the FDA wants to make it even easier to get these devices on the market.

First of all, there are some important concepts that we need to address:

  • FDA Classifications: The FDA classifies devices into three categories – Class I includes devices with the lowest risk and Class III devices present the highest risk. For example, Class I devices include enema kits and bandages (47% of devices fall into this category), Class II devices can be certain pregnancy tests and wheelchairs (43%), and Class III devices are implanted and high risk and may be pacemakers, breast implants, and more (10%).
  • What is the 510k process?:  This process is shorter than the normal FDA approval time since it bases its new drug or device on an existing one that has already been FDA approved. The company compares and contrasts the new versus the old product and explains why any differences between them should be acceptable.

The Problem with the Current 510k Process

Unfortunately, the current 510k format has some serious flaws in it and shortening the time period for approval seems like it will only make things worse. For example, transvaginal mesh (TVM). Vaginal mesh was never tested in one vagina before it was put into millions of women because it was based on an approved hernia mesh. The ProteGen sling was approved by the FDA and was the basis for future products. However, the Protegen sling was recalled in 1999 due to complications. Now TVM has been banned or halted in countries around the world, but only after slicing organs, causing chronic pain, and creating other horrific complications in hundreds of thousands of women (and it is STILL legal and commonly used in the U.S.).

If that doesn’t scare you, maybe this Yale report will: Seventy-one of the 222 drugs approved between 2000 – 2010 were withdrawn, required a “black box” warning (the strongest FDA warning), or required safety announcement about new risks. That’s one-third of all new drugs that were put on the market!

So here’s the takeaway: maybe the FDA should make sure that the drugs that are being put on the market should be safer before they flood the market with an increased number of volatile drugs and medical devices. Our health depends on it.


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Sources
“FDA launches pilot to shorten some 510(k) approval times”. MedDesign & Outsourcing. Accessed October 8, 2018. https://www.medicaldesignandoutsourcing.com/fda-launches-pilot-to-shorten-some-510k-approval-times/?webSyncID=ca181884-e69a-06d8-d511-aaac85cb754a&sessionGUID=85ce5878-e899-bdc4-8c5c-e2d129469e0b&spMailingID=14357543&spUserID=Mjk4ODUzMDA1MTY5S0&spJobID=1500150159&spReportId=MTUwMDE1MDE1OQS2
“Eliminating Routine FDA Re-review of Third Party 510(k) Reviews”. FDA. Accessed October 8, 2018. https://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/PremarketSubmissions/ThirdParyReview/UCM620308.pdf
“510(k) Clearances”. FDA. Accessed October 9, 2018. https://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/DeviceApprovalsandClearances/510kClearances/default.htm
“Learn if a Medical Device Has Been Cleared by FDA for Marketing”. FDA. Accessed October 9, 2018. https://www.fda.gov/medicaldevices/resourcesforyou/consumers/ucm142523.htm
https://www.policymed.com/2011/07/institute-of-medicine-report-medical-devices-and-the-publics-health-the-fda-510k-clearance-process-a.html
“One-Third Of New Drugs Had Safety Problems After FDA Approval”. NPR. Accessed October 16, 2018. https://www.npr.org/sections/health-shots/2017/05/09/527575055/one-third-of-new-drugs-had-safety-problems-after-fda-approval