Pharmaceuticalmedicals.com Reviews

Pharmaceutical Medical Devices Off-Label

What is a Pharmaceutical Product or Medical Device?

Pharmaceuticals are chemical in nature and are designed to actively interact with the body's metabolic or immune system. Therefore, the risks associated with a pharmaceutical are much higher than those of a medical device.

Medical devices are a mechanical in nature and have no active interaction with the human body. They range from simple tongue depressors and bedpans to complex programmable pacemakers and closed loop artificial pancreas systems. They also include in vitro diagnostic products such as reagents and test kits and radiation-emitting electronic devices with a medical use such as ultrasound equipment and x-ray machines.

Some products that meet the definition of both a drug and a medical device are classified as biologics. These are regulated by the Center for Biologics Evaluation and Research (CBER). Other products may be regulated by another Center within FDA, depending on their intended use. For example, drugs are regulated by the Center for Drug Evaluation and Research (CDER) and vaccines are regulated by the Center for Vaccine Research and Review.

What is an Off-Label Use?

A drug is considered off-label if it is prescribed for a condition, patient population or dose that does not have FDA approval. Medications are often used off-label because the FDA approval process is lengthy and expensive. Off-label treatment has risks because the benefits and side effects of the drug for that use have not been well studied.

However, doctors are allowed to prescribe drugs for off-label uses because good medical practice and patient interests call for it. The FDA advises healthcare providers to be well informed about the medication they are prescribing and that off-label prescriptions should be based on strong scientific support.

However, pharmaceutical companies are prohibited from directly promoting off-label use for their products. This is to prevent physicians from being influenced by marketing campaigns. It also prevents patients from misusing a drug in a way that has not been approved by the FDA. This can be dangerous to the health of a patient.

How is a Pharmaceutical Product or Medical Device Regulated?

Pharmaceutical companies and medical device manufacturers can run afoul of federal False Claims Act prohibitions on promoting products for off-label uses that are not reimbursed by federal or state health care plans. Such activity can involve false or misleading off-label marketing or promotion, or illegal kickbacks or other forms of compensation to healthcare organization leaders who may recommend the device or drug to their patients.

In the EU, medical devices are regulated by national competent authorities through notified bodies (commercial organisations accredited by individual member states to assess medical devices). Medical device manufacturer must place a 'Conformite Europeenne' mark on their products after passing a conformity assessment.

Some products fall on the borderline between medicines and medical devices and it is their intended purpose and mode of action that determines their regulatory status. If you have a question about whether a product falls within this category, contact the MHRA using the Borderline Advice Form. The MHRA will only respond to up to 4 product enquiries at a time.

How is a Pharmaceutical Product or Medical Device Promoted?

Drug promotion is an inevitable tool in the pharmaceutical industry that can help in both revenue generation and dissemination of updated medical knowledge. However, it can veer into the border of business ethics and legality if not done with strict compliance to various guidelines formulated by different governing bodies and industry trade groups.

Direct marketing through the use of medical representatives (MRs) remains the mainstay of pharmaceutical promotion across the globe with expenditure on this account reaching 20.4 billion USD annually. This includes bringing in physicians to engage with the company on a broader scientific level and the practice of appointing designated key opinion leaders or thought leaders who can promote the drug in question.

MRs are usually science graduates recruited through a rigorous process and trained to gather details on physicians’ practices, habits and interests for the purpose of drug promotion. They may be encouraged to promote drugs for off-label uses which can lead to submitting false claims to healthcare programmes such as Medicare in the USA. This is a clear violation of the False Claims Act.