Unapproved prescription drugs pose significant risks to patients because they have not been reviewed by FDA for safety, effectiveness or quality. Without FDA review, there is no way to know if these drugs are safe and effective for their intended use, whether they are manufactured in a way that ensures consistent drug quality or whether their label is complete and accurate. Unapproved drugs have resulted in patient harm, and the agency works to protect patients from the risks posed by these drugs.
At that point, the molecule changes in legal status under the Federal Food, Drug, and Cosmetic Act and becomes a new drug subject to specific requirements of the drug regulatory system.
Preserving Patient Access to Medically Necessary Drugs
The agency balances its goal to eliminate unapproved prescription drugs from the market with patient access to medically necessary drugs. FDA carefully considers the possible effects on patient access, including whether any action would likely lead to a disruption in the drug supply, before initiating an action against an unapproved drug.
The agency permits some unapproved drugs to be marketed if they are relied on by health care professionals to treat serious medical conditions when there is no FDA-approved drug to treat the condition or there is insufficient supply of FDA-approved drugs.
FDA Approval is Required by Law
Federal law requires all new prescription drugs in the U.S. be shown to be safe and effective for their intended use prior to marketing. However, some drugs are available in the U.S. even though they have never received the required FDA approval. Many health care professionals and patients are unaware that some of the drugs prescribed are not FDA approved.
Drug names are often subject to legal regulation, including approval for new drugs (to avoid confusion with existing drugs) and on packaging to establish clear rules about adulterants and fraudulent or misleading labeling. A national formulary is often designated to define drug names (and purity standards) for regulatory purposes. Revenue generated from drug production in the United States has more than doubled in the past 10 years. In 2016 alone, the U.S. Brought in more than $328.6 billion in prescription drugs sold in. The drugs most commonly shown in films are cocaine, heroin, LSD, cannabis (see stoner film) and methamphetamine. There is extensive overlap with crime films, which are more likely to treat drugs as plot devices to keep the action moving. The following is a partial list of drug films and the substances involved.
FDA permits some unapproved prescription drugs to be marketed if:
- the drug is subject to an open drug efficacy study implementation (DESI) program proceeding,
- health care professionals rely on the drug to treat serious medical conditions when there is no FDA-approved drug to treat the condition,
- there is insufficient supply of an FDA-approved drug.
The law allows some unapproved prescription drugs to be lawfully marketed if they meet the criteria of generally recognized as safe and effective (GRASE) or grandfathered. However, the agency is not aware of any human prescription drug that is lawfully marketed as grandfathered.
Unapproved Drugs Program
The agency’s Unapproved Drugs Program has a two-prong approach to help assure patient safety. First, the agency encourages manufacturers of unapproved drugs to obtain approval to be legally marketed in the U.S. Second, FDA has worked to remove unapproved drugs from the market. Many potentially unsafe drugs have been removed from the market since 2006, including several drugs with significant safety concerns. The agency uses a risk-based approach, giving enforcement priority to drugs that pose the highest risk to public health, without imposing undue burden on patients or unnecessarily disrupting the availability of drugs on the market.
In 2011, FDA issued a final guidance, Guidance for FDA Staff and Industry, Marketed Unapproved Drugs – Compliance Policy Guide, Section 440.100: Marketed New Drugs Without Approved NDAs or ANDAs, which describes FDA’s enforcement priorities.
Search Marketed Drugs Listed with FDA, Including Unapproved Drugs
Drugs marketed in the U.S., with or without FDA approval, can be identified in the following databases:
- National Drug Code (NDC) Directory publishes data derived from information submitted to the agency as part of drug listing requirements, including information on unapproved drugs. NDC numbers are provided for all listed drugs, regardless of approval status. Information in the directory does not indicate that FDA has verified the information provided.
- Drugs@FDA lists information on FDA-approved drugs since 1998, including patient information, labels and approval letters.
- Orange Book identifies FDA approved drugs.
Unapproved Drugs and Drug Prices
There are many factors that contribute to drug pricing. When there is a sole source of an FDA-approved drug, market dynamics may enable the company that sought approval to set a higher price than when the drug faces competition. Patients and health care professionals can, however, have confidence that the FDA-approved version has been shown to be safe and effective for its intended use and that it is manufactured according to federal quality standards.
While FDA does not have the authority to regulate drug prices, it is keenly aware of price fluctuations that can occur on the heels of its regulatory actions and takes steps within its authority to minimize the duration, if not the extent, of those price hikes. Although following the FDA approval process may result in cost increases for a drug over the short term, the risks to the individual patient are substantially reduced and the benefits are assured for the long term.
For More Information
- Ashley, Donald D., Clarifying Misconceptions About US Food and Drug Administration Unapproved Drugs Program, Anesthesia & Analgesia, December 2018, Volume 127 (6), p 1292–1294, 2018 International Anesthesia Research Society
- Marketed Unapproved Drugs -- Compliance Policy Guide (PDF - 164KB)
This is a reminder that the U.S. Department of Transportation (DOT) drug testing program will soon require testing for four semi-synthetic opioids (i.e., hydrocodone, oxycodone, hydromorphone, oxymorphone). The change is effective January 1, 2018.
What does this mean for the employees?
Beginning January 1, 2018, in addition to the existing DOT drug testing panel (that includes marijuana, cocaine, amphetamines, phencyclidine (PCP), and opiates), you will also be tested for four semi-synthetic opioids (i.e., hydrocodone, oxycodone, hydromorphone, oxymorphone). Some common names for these semi-synthetic opioids include OxyContin®, Percodan®, Percocet®, Vicodin®, Lortab®, Norco®, Dilaudid®, Exalgo®.
If you test positive for any of the semi-synthetic opioid drugs, then as with any other drug test result that is confirmed by the laboratory, the Medical Review Officer (MRO) will conduct an interview with you to determine if there is a legitimate medical explanation for the result. If you have a valid prescription, you should provide it to the MRO, who will determine if the prescription is valid. If a legitimate medical explanation is established, the MRO will report the result to your employer as a ‘negative’. If not, the MRO will report the result to your employer as ‘positive’.
As it has been the requirement in the past, when your employer receives a ‘positive’ drug test result, your employer is to immediately remove you from performing safety-sensitive functions and provide you with a list of qualified Substance Abuse Professionals (SAP) available in your area. In order to return to performing safety-sensitive functions for any DOT-regulated employer, you must complete the return-to-duty process that will include an evaluation by a SAP, who will require education and/or treatment. The SAP will determine if you successfully completed the prescribed education and/or treatment. Before an employer could return you to safety-sensitive work, the employer must get a negative result on a directly observed return-to-duty drug test. After you return to safety-sensitive work, you must be subject to directly observed follow-up testing for 12-60 months depending on the SAP’s recommendations.
Do I need to tell anyone about my prescribed medications?
Your employer may have a policy that requires you to report your prescribed medications to them. So check with your employer. If your job function has DOT-regulated medical standards (truck/bus driver, airline pilot, mariner), the DOT agency regulation may require you to report your prescribed medications to those who approved your medical qualifications.
What should I tell my prescribing physician?
If you are taking any prescription medications, consider this to be a reminder to have a conversation with your prescribing physician to discuss your safety-sensitive work. Be proactive in ensuring that your prescribing physician knows what type of transportation-related safety-sensitive work you currently perform. For example, don’t just provide a job title but describe your exact job function(s) or ask your employer for a detailed description of your job function that you can give to your prescribing physician. This is important information for your prescribing physician to consider when deciding whether and what medication to prescribe for you. It is important for you to know whether your medications could impact your ability to safely perform your transportation-related work.
Subject: New Drug Names Meanings
Will the MRO report my prescribed medication use/medical information to a third party?
Subject: New Drug Names In America
Historically, the DOT’s regulation required the MRO to report your medication use/medical information to a third party (e.g. your employer, health care provider responsible for your medical qualifications, etc.), if the MRO determines in his/her reasonable medical judgement that you may be medically unqualified according to DOT Agency regulations, or if your continued performance is likely to pose a significant safety risk. The MRO may report this information even if the MRO verifies your drug test result as ‘negative’.
As of January 1, 2018, prior to the MRO reporting your information to a third party you will have up to five days to have your prescribing physician contact the MRO. You are responsible for facilitating the contact between the MRO and your prescribing physician. Your prescribing physician should be willing to state to the MRO that you can safely perform your safety-sensitive functions while taking the medication(s), or consider changing your medication to one that does not make you medically unqualified or does not pose a significant safety risk.
Subject: New Drug Names List
NOTE: This document informally summarizes some of the effects of recent changes to the Procedures for Transportation Workplace Drug and Alcohol Testing Programs that are important for transportation employees, but it should not be relied upon to determine legal compliance with those procedures.
December 11, 2017
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