Opinion requested: Should regulatory bodies be strengthened as individual agencies?

My answer? No. I believe the most effective way to regulate is to create a single agency designed to help create laws and regulate all healthcare organizations, from pharmacy, to hospital, to long term care facilities. Creating one regulatory body would not only allow for more efficient adoption of new policies, it would also be much easier to later unify the various sectors together in the forthcoming technology age. My reasoning is this: too many regulating bodies creates too much confusion. Just take a look at our current healthcare regulation. If you look at just pharmacy, each pharmaceutical business is first regulated by the federal government, ie. FDA and DEA, before then subsequently being regulated by the individual state boards of pharmacy. When it comes down to the states, state laws on pharmacy cannot be more lenient than a federal law, it CAN ONLY be more specific than federal law. So then you have to ask yourself, why doesn’t the federal law just become more clear and efficient?

Now some may argue that because each state is run differently and operates under different circumstances (ie. drivers for that state’s revenue), each state should thus be it’s own regulating body. Well yes I would agree for general business, but when we are talking about healthcare, it’s not the business we need to focus on, but the quality of care. The minimum standard for care should not be a variable, but an established baseline across the board. So then why not just have the federal government regulate all of healthcare? Not only would there be a faster adoption rate for any new policies or procedures, instead of wallowing around waiting for the states to come up with an approval or a law more specific, we would also reduce the number of potential errors that occur from misinterpretation of the federal guidelines, or not noticing the more strict modifications placed by the state. What’s more, the states base their own regulations off the federal statutes anyway, so why not just create a system that works for every state? This regulatory model would benefit all industries in the sector, including more importantly hospital.

Hospital regulation is, in effect, a mess because there are numerous organizations that regulate hospital organizations. Besides federal and state regulations from the Centers of Medicare and Medicaid Services (CMS), there are also private organizations each offering accreditation or prestige associated with an award from said respective organization. One of the largest of the private organizations, the Joint Commission for Accreditation of Hospital Organization (TJC or JCAHO), has almost 5,000 hospitals and almost 10,000 other healthcare facilities participating. The other two include the Healthcare Facilities Accreditation Program (HFAP) and Det Norske Veritas Healthcare, Inc (DNV). All three regulating bodies have been given “deeming authority” by CMS. What I notice when I look at how these organizations work, is our government has effectively given authority to these private organizations to essentially do it’s job for them. What’s more, each accrediting body requires annual fees to be paid to the organization by each hospital organization. Hospitals looking to get accreditation from any of these organizations have to, in essence, pay to play. Annul fees are on average about $11,000 per year for TJC and $25,000 and $23,100 on average yearly for HFAP and DNV respectively. Those are only the top three organizations, I haven’t included the numerous local accreditation organizations, such as the California Hospital Association, and smaller national organizations such as the American Hospital Association, all of which offer similar accreditation.

So what does that all mean? It means if we allow individual agencies to have more authority, we will only create mass confusion. What we need is only one regulatory agency per industry, for the entire sector. With just one agency having authority, we reduce the chaos of having multiple policies and accreditation. Yes, I think accreditation is important, because that creates a drive for the hospital to constantly improve upon itself, or at the bare minimum, continue operating at an established baseline for patient safety and effective care. However, having too many different options for accreditation creates confusion for both patients and policy makers. Which organization creates better policies, or focuses on improving patient care the most? In my opinion, rather than creating a whole new system, we should roll these existing organizations into CMS, and allow that newly created branch to continue regulating the industry as a unified collective. We continue to allow accreditation but establish varying grades for each organization. After all, one of the biggest reasons for having an accreditation is to be able to be listed as providers with CMS. Well, why do we need multiple organizations handing out accreditation for approval of healthcare providers for CMS? Why not just streamline the process and just have one organization?

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Opinion requested: Should regulatory bodies be strengthened as individual agencies?

7 thoughts on “Opinion requested: Should regulatory bodies be strengthened as individual agencies?

  1. David Zhou says:

    This article reminds me of a chapter from the book “Inside the FDA” by Fran Hawthorne. The chapter is rightfully titled “You Don’t Know Which Agency Is In Charge”. One example it gave was that even within the realm of food regulation, so many different agencies are involved. The Center for Food Safety and Applied Nutrition at the FDA regulates all food other than poultry and meat, which are regulated by the Department of Agriculture. Except for game meats like venison and ostrich, which fall under the FDA. The EPA regulates fish that are caught recreationally. But if they are sold commercially, they are then regulated by the FDA. In meat, the Department of Agriculture regulates meat for human consumption, but FDA regulates meat fed to animals. In genetically modified plants, the Department of Agriculture regulates the field testing of GM plants, EPA regulates GM plants that are altered to make their own pesticides, and FDA regulates GM plants that are fed to humans. It just goes to show that so many departments and agencies compete for jurisdiction. Good thing or bad thing, I am not too sure.

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    1. That’s exactly the issue. There are too many agencies to regulate different facets of the same industry. For instance, during the clinical phase trials, the pharma companies must submit their clinical data to both the FDA as well as CDER or the Center for Drug Evaluation and Research. It’s actually CDER that regulates more of the clinical trials process, but the final data must be submitted to the FDA for review of whether or not that NDA becomes available to the market. I’m almost certain that during that final approval process, some information must be submitted again to the FDA. The question is, why not just allow CDER the regulatory authority to do this? They’ve been involved in every step of the way anyway, and likely have a much better understanding of the data. Such a system would streamline the final review process of the IND application.

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  2. It is. I may have worded my response incorrectly. What I meant was that during the final review process, CDER sends out requests for multiple advisory committees to join in the final decision process, which in all likelihood delays the process. Instead of spending time on this, I think if they were able to handle everything in house, thereby speeding up the application review process.

    What I am trying to say is, if they remove the need for advisory committees, we may avoid the proverbial “meetings about meetings”. Now, in all honesty, I have never been to one of said advisory committee meetings, perhaps they are necessary, perhaps they are not. My perspective is that following the trend of which our government operates, I can only assume that said meetings may potentially drag the application process out longer than necessary.

    Even if there is a critical need for such advisory committees, each NDA application takes months to years of prep time, so why were these advisory meetings not already concluded in advance of the final application review? Phase II data usually should have established enough data to at least begin the process. By phase II, it’s most likely established what the NDA’s target indications and target patient population, so why wait until all the data is in to begin review? That’s the point I am trying to make.

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    1. David Zhou says:

      Yeah i see your point. I do know that the advisory committees consist of various stakeholders like academics, consumer representative, industry representative(non-voting), and patient representative. If I was the FDA, I would definitely have advisory committee meeting because 1) receive more feedback from all stakeholders that will be affected by this new drug 2) conduct due diligence in case the drug gets recalled later on, less chance of serious litigation if other experts have also reviewed and accepted FDA’s work. So I do think it is an issue of timing of these advisory meetings.
      The risk of commissioning a drug is so much greater than the risk of omitting a drug, and the advisory meeting can lower some of that risk of commission. Just my opinion.

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    1. Agreed that the committees are likely necessary, but perhaps poorly timed. I’m not sure about the timestamp issue. I set up the site as default on the east coast so I’m not sure why it is switching around. I’ll take a look at it.

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