Skin Disorders and Healthcare Compliance

Everyone experiences itchy skin at some point in their life. Many people suffer other skin disorders some of which can be quite painful, may be permanent, and may cause severe harm. Some disorders may be life-threatening.

In response to these disorders, there are numerous prescription and over-the-counter drugs that are manufactured and prescribed to treat skin disorders. Part of the treatments may also include recommendations about the best foods to eat and the use of various cosmetics. Even when people are feeling well, people who don’t like the appearance of their skin seek nutritional and cosmetic help.

At Cohen Healthcare, we advise both developers of new drugs, foods, and cosmetics about their healthcare compliance issues. We also advise physicians such as dermatologists, primary care physicians, and other healthcare providers about the healthcare regulations that apply to their medical practices. Our team understands how much money and time businesses invest to develop, promote, and market their products and services. We understand the federal and state laws and regulations that govern the manufacture, sale, and use of drugs, cosmetics, dietary supplements, nutritional products, and cannabis products.

There can be severe consequences for noncompliance including – warning letters, injunctions, civil actions, criminal actions, import alerts, exclusion from certain programs such as Medicare and Medicaid, and other consequences. We advise clients about their FDA and FTC compliance issues, Stark Law, the Anti-Kickback Statute, HIPAA, and many other federal laws and state laws.

Generally, drugs need to be approved by FDA through the use of a New Drug Application (NDA). Many foods and cosmetics may be considered drugs if the products claim to be treatments for a disorder such as a skin disorder.

Types of Skin Disorders

Some of the many different types of skin disorders, conditions, and diseases – according to the US National Institutes of Health are:

• Acne. Acne is caused “when blocked skin follicles from a plug caused by oil from glands, bacteria, and dead cells – clump together and swell.” The treatments for Acne focus on preventing new lesions from forming and preventing scarring. Common treatments include topical medications that are applied to the skin. The medications come in gels, creams, lotions, soaps, and pads. Side effects may include burning and irritation. A dermatologist or physician may prescribe oral medications such as antibiotics, retinoids, hormone therapy, and corticosteroids. For some patients, more invasive treatments such as laser therapy, chemical peels, and surgical procedures may be necessary.
• Alopecia areata. This skin condition attacks the hair follicles – often causing the hair to fall out. FDA has not yet approved any drugs to treat alopecia areata. The NIH states that some cosmetics can help disguise the loss of the hair on the eyebrows.
• Atopic dermatitis. This condition is a skin disease that causes itching that can result in redness, crusting, scaling, cracking, and weeping clear fluid. The treatments vary depending on the location and extent of the rash and itching. Various medications including corticosteroid creams and ointments, moisturizers, Calcineurin inhibitors, Phosphodieterase-4 inhibitor, and biological medications are used to treat atopic dermatitis. Physicians may recommend skin care to keep the moisture in and photo (light) therapy.
• Epidermolysis Bullosa. This skin disorder is a group of diseases that can cause painful blisters and infections. The treatments focus on managing the symptoms. There is no cure for the disease. Treatments include pain medications, skin care, reducing the risk of infection, and good nutrition.
• Hidradenitis Suppurativa (HS). “Hidradenitis suppurativa (also known as acne inversa) is a chronic, noncontagious, inflammatory condition characterized by pimple-like bumps or boils and tunnels or tracts on and under the skin.” The treatments include efforts to reduce the skin lesions and prevent the disease from progressing.

“A TNF inhibitor, from a class of medications known as “biologics,” is approved for the treatment of moderate to severe HS. Other medications used in the management of HS include antibiotics, corticosteroids, immunosuppressants, retinoids, hormone therapy, and approved treatments for other medical conditions. Laser hair removal may also prove beneficial.”

• Ichthyosis. This is a dry, thickened skin condition that can look like fish scales. Treatments include hydration, retinoids, and prescription creams and ointments.
• Pachyonychia Congenita. This rare condition causes “thick nails and painful calluses on the bottoms of the feet and other symptoms.” There no cures or therapies. The treatments focus n managing the pain.
• Pemphigus. This is a skin disease in which the immune system attacks healthy cells located in the skin’s top layer – resulting in blisters. The treatments aim to control the disease. Treatments include anti-inflammatory medications, immunosuppressants, biological response modifiers, antibiotics, antivirals, and antifungal medications. Treatments may also include plasmapheresis and intravenous immunoglobulin therapy.
• Psoriasis. This is a skin disease that causes scaly, red skin. The skin may be swollen and feel hot or painful. The treatments include phototherapy and various medications. The medications include topical therapies, oral therapies, retinoids, methotrexate, and other medications.
• Raynaud’s Phenomenon. This is a skin disease that affects blood vessels. The disease causes a patient’s hands and feet to lack a sufficient amount of blood. “While there are no medications approved by the U.S. Food and Drug Administration for Raynaud’s phenomenon, medications that have been approved for other conditions are routinely used to treat it.” Surgery may also be required.
• Rosacea. This serious skin disease causes reddened skin and pimples, usually on the face. The eyes may also be affected. The treatments include various medications, laser and light-based therapies, and surgery.
• Scleroderma. “Scleroderma causes patches of tight, hard skin, but can also harm your blood vessels and organs.” The treatments include anti-inflammatory medications to manage pain and reduce swelling, corticosteroid topical creams, and other medications.
• Vitiligo. With this skin condition, patches of a patient’s skin turn white – because the cells that color the skin are destroyed. “Most treatments for vitiligo focus on stopping the immune system from destroying the melanocytes and improving the skin’s appearance.” The treatments include medications, phototherapy, and depigmentation. Surgery may be recommended for some patients

Other serious skin conditions, according to Healthline.com include:

• Cold sores
• Blisters
• Hives
• Actinic keratosis
• Carbuncles
• Eczema
• Cellulitis
• Measles
• Various types of cancer such as basal cell carcinoma, squamous cell carcinoma, and melanoma
• Lupus
• Warts
• Chickenpox
• Impetigo
• Other disorders

Food, Drugs, and Cosmetics Regulated by the FDA

The US Federal Food, Drug, and Cosmetics Act of 1938 (FD&C Act) governs the safety of not just foods, drugs (prescription and non-prescription), and cosmetics – but also dietary supplements, medical devices, and biologics. The law focuses on healthcare products that enter into interstate commerce. The purpose of the FD&C Act is to protect consumers from dangerous products that may affect their health and safety. The core part of the FD&C Act that applies to skin disorders is the prohibition of products that are considered adulterated or misbranded. The Ac is enforced by the U.S. Food and Drug Administration (FDA).

How are drugs defined?

According to FDA, “products are drugs under section 201(g)(1) of the FD&C Act, 21 U.S.C. 321(g)(1), because they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease and/or intended to affect the structure or any function of the body.”

How are cosmetics defined?

Cosmetics are defined by FDA as “articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body…for cleansing, beautifying, promoting attractiveness, or altering the appearance.” “Included in this definition are products such as skin moisturizers, perfumes, lipsticks, fingernail polishes, eye and facial makeup preparations, shampoos, permanent waves, hair colors, toothpastes, and deodorants, as well as any material intended for use as a component of a cosmetic product.”

Generally, cosmetics (and dietary supplements) do not require premarket approval while drugs, medical devices, and other products governed by the FD&C Act do require premarket approval. Our experienced healthcare lawyers understand when premarket approval is necessary and when it’s not – depending on the type of product involved.

Generally, if there are claims that a skincare product such as skin cream can treat a skin condition – that product may be classified as a cosmetic and a drug.

According to FDA:

• “Products intended to cleanse or beautify are generally regulated as cosmetics.”
• “Products intended to treat or prevent disease, or affect the structure or function of the body, are drugs.”
• “Some products are both cosmetics and drugs. Examples include anti-dandruff shampoos and antiperspirant-deodorants, as well as makeup with SPF (sun protection factor) numbers. The products must meet the requirements for both cosmetics and drugs, as applicable.”

There are additional FDA requirements for any foods, dietary supplements, or other products that are used to help patients with skin disorders.

What are adulteration and misbranding of drugs, cosmetics, and other products?

Many skin care products are considered adulterated or misbranded because the products generally promise to diagnose, cure, mitigate, treat, or prevent skin core disorders and diseases without approval by FDA and without the necessary scientific evidence.

• Drugs are considered adulterated according to Section 501(b) of the Food, Drug, and Cosmetic Act (the Act) if the drugs fail to conform to compendial standards of quality, strength or purity. According to the law, adulteration includes preparation, packing, or holding under insanitary conditions. Adulteration includes failure of the manufacture, processing, packing, or holding to conform with current good manufacturing practices “to assure that such drug meets the requirements of this chapter as to safety and has the identity and strength, and many other requirements.”
• Products such as drugs and cosmetics are considered misbranded if the labeling, promotion, or is false or misleading in any particular, and for many other reasons including the failure to include proper warnings, and wording.

Examples of FDA Warning Letters

FDA enforcement actions include the issuance of warning letters. If medical companies and medical practices fail to comply with these warning letters, FDA normally works with the US Department of Justice to enforce the warnings. The DOJ may seek injunctions, seize products, request that civil penalties be imposed, and/or seek criminal penalties – among other actions.

FDA may issue warning letters based on a review of the following:

• An investigation of the manufacturing site.
• The labeling, packaging, and printed marketing materials.
• The company website and all the claims that are made on the website.
• The social media sites and all the claims that are made on these sites on behalf of the manufacturer.
• Other evidence.

The manufacturers, distributors, and sellers of skin care products need to understand how FDA will classify their products – whether the products are drugs, cosmetics, or other types of products. An improper classification can result in warning letters and numerous enforcement actions. Many treatments for skin disorders do include products that may qualify as both drugs and as cosmetics. Some products may also qualify as dietary supplements and other products that are regulated by FDA.

Claims about what the products do and how well the products help patients may also be governed by the Federal Trade Commission. The FTC will review if the claims are dishonest or misleading.

The manufacturers and medical practices need to ensure they are always acting in the best interests of the patient and not their financial worth. Skilled healthcare lawyers explain when referral arrangements might violate Stark Law and/or the Anti-Kickback Statute (AKS). Our lawyers explain what exceptions to Stark Law and what safe harbors to the AKS may apply.

Manufacturers and physicians should contact Cohen Healthcare Law Group, PC to review the federal and state laws and regulations that govern the treatment of skin disorders and diseases. Our experienced healthcare attorneys help medical businesses and medical practices understand their compliance duties and what proactive steps to take to help show compliance.