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CDER 2007 Update
Drug Safety and Quality
Monitoring drug safety
We monitor the use of marketed drugs for new or emerging information about the health risks of these products. As risks are detected, we inform the public and health-care providers so they will have the latest information when making prescribing and use decisions. In addition, we develop policies, guidance and standards for drug labeling, current manufacturing practices, clinical and laboratory practices and industry practices. Our goal is to ensure the greatest benefits of drug therapies while minimizing their risks.
Advertising and drug information
It is critical to receive accurate information to ensure the appropriate use of drugs. We regulate the information that comes with an over-the-counter drug. Previously, drug companies promoted their products almost exclusively to physicians. Now companies advertise directly to consumers. We oversee advertising of prescription drugs, whether to physicians or consumers, by ensuring that drug advertisements and other promotional materials are truthful and balanced. Drug advertisements must contain an accurate summary of information about a drug’s effectiveness, side effects and circumstances when its use should be avoided.
Protecting drug quality and safety
We also set standards for drug quality and manufacturing processes. We enforce federal requirements for drug approval, labeling, and manufacturing to ensure a safe and effective drug supply. As the pharmaceutical industry has become increasingly global, we cooperate with other nations to harmonize standards for drug quality and approval. We base decisions to approve a drug—or to keep it on the market if new safety findings surface—on a careful balancing of risk and benefit. We also consider the tools we have to help minimize the risks to patients from a drug’s use. As all drugs have risks, we tolerate higher risks for drugs that treat serious and life-threatening conditions that have no or few treatment options. We consider many issues both in approving a drug as well as monitoring it after approval including:
- Who will be using the drug and how it will be used?
- Will the drug be used by older people or children?
- Will it be used with other medications leading to side effects from interactions?
- Will it be administered by a physician, or will consumers be able to buy it over the counter?
- How serious and common are the drug’s side effects compared to the seriousness of the disease being treated?
Comprehensive oversight of drug safety
Our professional staff spends about one-half their time addressing safety issues, including:
- Watching for problems once we approve a drug.
- Overseeing clinical trials.
- Evaluating new therapies and new or expanded uses for existing therapies to balance risks against expected benefits.
- Overseeing manufacturing, distribution and promotional activities.
- Preventing medication errors by evaluating proposed proprietary names, labeling and packaging.
- Developing proactive risk management strategies both before and after approval.
Types of risks from medicines
The practical size of premarketing clinical trials means that we cannot learn everything about the safety of a drug before we approve it. A degree of uncertainty always exists about the risks of drugs. This uncertainty requires our continued vigilance, along with that of the industry, to collect and assess data during the post-marketing life of a drug. Categories of medicine risks include:
- Product quality defects. These are controlled through good manufacturing practices, monitoring and surveillance.
- Known side effects. Predictable adverse events are identified in the drug's labeling. These cause the majority of injuries and deaths from using medicines. Some are avoidable, and others are unavoidable.
- Avoidable. In many cases drug therapy requires an individualized treatment plan and careful monitoring. Other avoidable side effects are known drug-drug interactions.
- Unavoidable. Some known side effects occur with the best medical practice even when the drug is used appropriately. Examples include nausea from antibiotics or bone marrow suppression from chemotherapy.
- Medication errors. The drug is administered incorrectly or the wrong drug or dose is administered.
- Remaining uncertainties. In addition to rare events occurring in about 1 in 10,000 persons, these include long-term effects and unstudied uses and populations.
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Date created: July 31, 2008 |
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