Reflection 10/27

This week we learned about Federal Regulation with Dr. Baker. When it comes to regulation there is much to take in because there are many boxes to check state and federal wise. The US is one of the most efficient countries when it comes to regulating the drugs brought to market. The reason for doing so is because with healthcare resources being so scarce, there is no room for medical errors. This means that the regulatory committees want to get drugs to patients that are safe and effective that will not cause controversy in the future. The FDA's job is to decide what is actually considered a drug, whether this drug is going to need a prescription or can be over the counter, double check marketing efforts of the drug, and then finally make sure that all drugs that need proper FDA documentation have it. To those trying to experiment with drugs, they may see this process to be over bearing but it is specifically put in place to make sure that patients are receiving proper care. The over all purpose of the health care system is to cure, manage, and treat conditions in order to make the quality of life for a patient better. Although the FDA has many jobs, they are not in charge of decided who is able to prescribe, administer, and dispense drugs; this is up to the state. The reason this occurs is because each state has their own legislation when it comes to certain conditions such as contraception or marijuana usage. This has caused much controversy over time as state and federal regulations can collide when it comes to the proper usage of a drug and whether it is misleading patients. When patients come to a pharmacy, doctors office, or hospital they have little knowledge of the drugs they need or want. They may do research to try and learn more about them but in reality they are in the dark about the side affects and adverse events that can occur from a drug. This is why the FDA takes over the counter and prescription drugs seriously. A prescription drugs must not be misleading, have false information, use another drugs name and must conform to standards in terms of storage and deterioration. Prescription drugs call for a middle man of the physician or perscriber. The labeling of these drugs must have proper naming and dates in order to simply show what the drug is , who prescribed it, who it is for, how much should be take and when as well as when the drug can no longer be effective. The FDA does this in order to avoid any conflict if patients take the drug the wrong way or try to prove it was ineffective. Prescription drugs have their limits tho. When a drug is patented it has 20 years in the market before generic company's can start duplicated the compound. Twenty years may seem like a lifetime for a drug but it is not; manufacturers struggle to keep their drug on the market as long as possible before loosing their prescription market. These manufacturers may try to submit a supplemental NDA in order to change the dosage of a drug to extend the rights to it for another three years. This means that they have three more years of revenue as an over the counter drug before they start losing money to generic competitors. There is such an grey area between prescribed and over the counter drugs that patients do not know. Like I said earlier, these patients have little not know information about the chemical composition of these drugs and how their body metabolizes them. To combat this concept, there are inserts put in with drugs that describe the basics of a 'need to know basis' for patients. The FDA does not demand this for all but there are a select few that the FDA mandates having an insert that they wrote. These are drugs that have more complex adverse events that can occur or addictive tendencies. When it comes to these drugs like controlled substances, there are different levels and classes of severity. This means that each level is treated differently in terms of how labeling and marketing should be performed. An individual who needs a drug of this strength may have clouded judgement when it comes to usage and dosage which is why the FDA makes sure that the outcomes of the drug are properly stated. A topic that was brought up in both the reading and in the lecture was medical marijuana. It is not federally legal but it is up to state jurisdiction on how the drug should be dispensed. The FDA has struggled to mandate regulations on the usage of marijuana because there is not much scientific evidence as to how it aids conditions. There is definitive positive affects of the drug but the concrete data is not there. Marijuana is placed in the same schedule as heroin as it is seen as not safe or effective for use and is and cannot be prescribed or dispensed. I find this interesting that the two drugs are grouped in the same area. On a personal basis I do not see the data that associates marijuana with addictive characteristics and life threatened outcomes. This is one of those topics an drugs that may never be resolved on the federal basis because there is too much controversy behind it. In this area I found an article on Drug Topics that is called "FDA,FTC Issue More CBD Manufacturer Warnings". The article talks about the fact that a company named Rooted Apothecary was selling CBD products online and on their social media promoting unfounded claims about them as well as marketing them as dietary supplements. They said that their products "treated teething pain and ear aches in infants, autism, attention-deficit/hyperactivity disorder, as well as Parkinson’s and Alzheimer’s disease, among other conditions or diseases". The FDA found that these declarations were not accurate and that some of their products did not even contain the amount of CBD they declared. According the "Federal Trade Commission Act, it is unlawful to advertise that a product can prevent, treat, or cure human disease unless the advertiser possesses competent and reliable scientific evidence, including, when appropriate, well-controlled human clinical studies, substantiating that the claims are true at the time they are made". This shows that even tho the dispensing of marijuana resides within the state, there is some unlawful events occurring that the FDA and FTC are trying to crack down on in order to promote safe and effective drugs that will not cause problems with patients.  I think that the FDA and FTC do a great job currently regulating drugs since there are so many abusers out there. Drugs are something that once the prescription has been filled, it is in the hands of the patient to properly use the drug as required. If they abuse this action then it is not the fault of the FDA, FTC, or manufacturer because they did all they can do to show the patient the consequences of their actions. The regulation of drugs is something that stabilizes the health care industry today and I am sure it something that will become more strict as time goes on.