Articles Posted in Over-the-counter

handsoap.jpgOn December 17, 2013, the FDA issued a Proposed Rule for consumer antiseptic wash drug products. Prior to this Proposed Rule, the last Tentative Final Monograph (“TFM”) issued for antiseptic active ingredients was in 1994 (59 Fed. Reg. 31,402), which classified 22 active ingredients for over-the-counter (“OTC”) antiseptic handwash use.

The new Proposed Rule affects manufacturers of antibacterial hand soap and hand and body wash products containing OTC antiseptic active ingredients for repeated daily use, to be used with water. Those products do not include hand sanitizers or wipes. Additionally, the Proposed Rule is only to evaluate consumer antibacterial products and not health care setting antibacterial products, which have distinct proposed use settings, target populations, and risks for infection.

The Proposed Rule requires manufacturers of antibacterial soaps and washes to: (1) demonstrate the products are safe for long-term daily use; and (2) demonstrate with clinical data that the products are more effective than plain soap and water in the prevention of illness and the spread of infection. The manufacturers have one year to submit new data demonstrating that safety and effectiveness. If a manufacturer cannot demonstrate those two requirements, then it will have to reformulate the product (remove the antibacterial active ingredient).
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antiaging.jpgOn October 5, FDA sent a warning letter to Avon Products, Inc. (“Avon”) concerning the cosmetic company’s online promotion of its anti-aging skin care products. The letter, which FDA posted last week, objects to Avon’s marketing claims for a variety of its anti-wrinkle products. Specifically, it warns that they “appear to be intended for uses that cause these products to be drugs under section 201(g)(1)(C) of the Federal Food, Drug, and Cosmetic Act [‘FD&C Act’].”

The cited statutory provision (21 U.S.C. § 321(g)(1).) defines “drug” to include “articles (other than food) intended to affect the structure or any function of the body of man or other animals.” FDA asserts that Avon’s marketing claims indicate that the creams and serums listed in the letter are intended to affect the structure of human skin tissue, in which case they would fall under that definition. For example, the company’s website describes that the Anew Clinical Advanced Wrinkle Corrector as “formulated to boost shock-absorbing proteins to help strengthen skin’s support layers,” and “start rebuilding collagen in just 48 hours.” While it is not out of the ordinary for anti-wrinkle products to claim to reduce the appearance of wrinkles and fine lines, FDA believes that Avon’s statements go too far. According to the letter, the products are “not generally recognized among qualified experts as safe and effective for the above referenced uses” and are thus new drugs, requiring marketing approval.

Written by Rachael P. McClure

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Congress has prohibited the introduction of new drugs into interstate commerce without filing, and subsequent approval of, a new drug application (“NDA”) as stated in 21 U.S.C. § 355(a). A new drug application (“NDA”) must include, among other things, “full reports of investigations which have been made to show whether or not such drug is safe for use and whether such drug is effective in use.” Id. at § 355(b)(1). Other requirements address labeling information and manufacturing controls. Id. The warning letter asks Avon to review its website and product labels and requests a response within 15 days of receipt (October 20) detailing the steps the company has taken to correct the alleged violations. At least some of the accused descriptions still seem to remain on Avon’s website.
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generic-drugs.jpgA research letter published online in the Journal of the American Medical Association (“JAMA”) last Tuesday reports findings that pharmaceutical advertisements have a tendency to minimize potential adverse effects when the products they promote become available over-the-counter (“OTC”). The researchers attribute this shift in content to the differences in prescription drug advertising standards, governed by FDA, and those for OTC advertising, governed by the Federal Trade Commission (“FTC”). FDA requires that ads present a “fair balance” of the risks and benefits of a drug, a requirement that is absent from FTC’s “reasonable consumer” standard. Commentators note that the FDA regulations are better equipped to ensure against “active deception.”

The research endeavor, sponsored by CVS Caremark, considered four drugs that transitioned from prescription to OTC status within the last ten years: Claritin® (loratidine), Prilosec® (omeprazole), Xenical®/Alli® (orlistat), and Zyrtec® (cetirizine). It examined 133 total television and print advertising materials from twenty-four months prior to, through six months after, each transition, and found that the percentage of advertisements that referenced side effects plummeted from 70% while prescription only to 11% once available OTC. Conversely, the proportion describing drug benefits jumped from 83% to 97%. The study further reports that OTC advertisements frequently omit the generic names of drugs, “a powerful tool for the patient as a consumer in that it helps tie together scientific information on the drug from different places.” Roughly 50% of the OTC ads mentioned the generic name, while over 95% had when the drugs were available by prescription only.

Written by Rachael P. McClure

IMG_0148.JPG On May 11, FDA reportedly told attendees of the Consumer Healthcare Product Association’s Regulatory & Scientific Conference in Washington, D.C. to be patient while FDA implements its “new paradigm” for prescription to over-the-counter (“Rx-to-OTC”) switch applications (The Tan Sheet (May 21, 2012). Andrea Leonard-Segal, M.D., Director, Division of Nonprescription Clinical Evaluation, Office of Nonprescription Products, Center for Drug Evaluation and Research, said that FDA’s anticipated, revised Rx-to-OTC regulations will allow for expanded conditions of safe nonprescription use.

Leonard-Segal acknowledged, however, that the process will take time, warning “if you submit [a new drug application] where we don’t have the regulations to support the switch, if you’re ahead of your time compared to the regulations, then I think the project won’t go where you want it to go.” While waiting for FDA to final the regulations, Leonard-Segal suggested that firms make business decisions about initiating switch programs that employ new diagnostic technologies and other measures, according to their internal estimate project timelines. Leonard-Segal, however, sympathized with sponsors that had failed to meet FDA’s current, less flexible regulations that only permit OTC conversions where the Drug Facts label has full comprehension. An example of failed Rx-to-OTC switches cited was statins to lower cholesterol, but other categories of products that may benefit from the new regulations are sleep aids and triptans to treat migraines.

Commenting further, Leonard-Segal said at the Conference: “One of the frustrations of being in the switch business . . . has been watching the regulations interfere with, what in my perspective have been some very interesting and very innovative ideas, but that just can’t move forward because the regulations don’t allow us to go there.” Leonard-Segal further noted that a priority for the new regulations will be to consider how diagnostic devices could work together with OTC drugs, which is currently a complex approval process involving multiple centers and considerations.
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by Kyle Deighan

IMG_0148.JPGFDA is currently exploring the possibility of allowing additional drugs for common health conditions to be sold over-the-counter (“OTC”) without a prescription. FDA held public hearings last week to gather input from various groups on the issue, including consumers, pharmacists, and health care community members. Janet Woodcock, M.D., Director, Center for Drug Evaluation and Research (“CDER”), explained, “What we are asking is, should there be more flexibility in the concept of nonprescription drugs? Can we broaden the assistance a consumer gets and increase the types of medicines that might be available over-the-counter?” Drugs that may soon be available OTC without a prescription include cholesterol, asthma, migraine and blood-pressure medications.

FDA may require special conditions to apply before a drug may be sold OTC. These could include requiring patients to speak with a pharmacist before obtaining a medication or undergoing some form of diagnostic test. Or patients may be required to first see a physician to obtain a prescription, but then could obtain refills without needing subsequent prescriptions. FDA has also discussed the use of kiosks in pharmacies or questionnaires on the Internet to help consumers determine whether or not to take a certain drug. Woodcock noted that “the rules for nonprescription status were established in an age when widespread access to information technology did not exist. The world is evolving. It is clear there are now many interactive mechanisms that can help consumers through the process of self-diagnosis and medication selection in a much more comprehensive manner than a few worlds on a fact box.”

Supporters argue that making more drugs available OTC would give patients the access they need to necessary medications. According to FDA, the time and cost required to visit a doctor, obtain a prescription, and then fill that prescription may deter patients from ever obtaining medications. An estimated 20 percent of patients with prescriptions do not even bother getting them filled, for example. Proponents argue that more OTC offerings would provide these patients with easier access to necessary drugs. Other benefits highlighted by FDA include “an increase in the appropriate use of medication, decreases in health costs, greater access to health screening … and better, more consistent treatment of common conditions.”
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by Kyle Deighan

prescription.jpgLast week, FDA warned health care professionals to exercise caution when dispensing the FDA-approved eye medicine DUREZOL® (difluprednate ophthalmic emulsion) 0.05% and the unapproved prescription topical wart remover DURASAL® (salicylic acid) 26%. This comes after several reports of injuries caused when patients expecting to receive DUREZOL®, the eye medicine approved for the treatment of inflammation and pain associated with ocular surgery, were inadvertently given DURASAL®, an unapproved wart remover. One such incident resulted in a $1 million lawsuit against Walgreens, filed by a man who put the acid wart remover in his eye after ocular surgery. Although the packaging contained the explicit instructions “not for use in eyes,” the man was using the eye drops to recover from eye surgery and was likely unable to read the warning. Perhaps the most troubling aspect of this story is that reports regarding possible confusion between DUREZOL® and DURASAL® go as far back as 2009.

In its report last week, FDA cautioned that pharmacists should exercise care when filling prescriptions for the eye medicine due to the potential for confusion between the names of the two medications. Obviously, this highlights a concerning issue that can arise with drugs that do not undergo the standard FDA approval process. Generally, as part of the drug approval process, FDA screens the proprietary names of proposed drugs for similarities with other products on the market. However, DURASAL® (the wart remover), did not undergo FDA’s approval process, and was not screened to evaluate potential name confusion with other approved products prior to entering the market. As we have written about previously (such as here), thousands of unapproved drugs remain on the market (including over-the-counter (“OTC”) drugs that also do not undergo a pre-approval process but are legal if they follow FDA’s monographs) and problems such as this continue to crop up. FDA encourages health care professionals and patients to carefully examine packaging and labeling to avoid confusion.

As for DURASAL®, according to FDA, Elorac Inc., the distributor of DURASAL®, has not responded to requests from FDA to remove the product from the market or recalled the product from shelves. DURASAL® contains an active ingredient approved for wart removal but in an amount that exceeds the maximum concentration permitted for an OTC drug, which is why it is an unapproved drug. Interestingly, Elorac Inc.’s website does not list DURASAL® as one of its products, yet information about DURASAL® is still available through Elorac when the page is accessed. Elorac continues to manufacture another product containing salicyclic acid in a slightly higher amount and in a different vehicle called VIRASAL®, which also does not appear to have FDA approval, based on FDA’s list of approved drugs. Both DURASAL® and VIRASAL® state on their prescribing labeling “Rx only / FOR TOPICAL USE ONLY. / NOT FOR OPHTHALMIC, ORAL OR INTRAVAGINAL USE”, which explains in part why some pharmacists may have been confused given that both DUREZOL® and DURASAL are labeled as prescription products.
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by Fitz Beckwith Collings

The Center for Inquiry (“CFI”) and its affiliate, the Committee for Skeptical Inquiry (“CSI”) – want to know why FDA has not yet regulated the labeling and sale of homeopathic drugs. On August 26, the organizations jointly filed three citizen petitions requesting that FDA “require all commercially available drugs to be proven effective and be adequately labeled for their intended uses.”


While homeopathic remedies have been on the market for some time, their use has become more widespread in recent years. Sales in the U.S. are approaching $1 billion, and CFI believes that this money would be better spent on remedies that have been proven as safe and effective as allopathic drugs. With flu season arriving, CFI’s petitions specifically target homeopathic drug manufacturer Boiron and its flu-treatment drug, Oscillo–the “#1 Pharmacist Recommended Brand” despite the Centers for Disease Control and Prevention’s (“CDC’s”) insistence that there is no scientific evidence that any homeopathic remedies have any benefit against influenza.

In its statement of grounds, CFI alleges that homeopathic drugs are no more effective than placebos. CFI asserts that the principles underlying homeopathy, which correlate increased dilution with increased effectiveness, result in over-the-counter (“OTC”) homeopathic drugs that are actually devoid of active ingredients. In a typical “24X” homeopathic preparation, for example, the “active” ingredient is diluted 1:10 24 consecutive times and the resulting drug contains (on average) not one molecule of the “active” ingredient. Boiron’s Oscillo product, by comparison, is a “200C” preparation (200 consecutive 1:100 dilutions), which CFI points out would contain only one molecule of the “active” ingredient in a volume more than 30 billion times the size of Earth.
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By Howard Rosenberg


Last week saw five reported cases of other manufactures’ drugs being found in Nurofen Plus packets. The anti-psychotic Seroquel XL had been found in four packets of Nurofen Plus in England and Neurontin, a prescription medicine for epilepsy, had been found in one packet of Nurofen Plus bought from an independent pharmacist in Northern Ireland.

As a consequence Reckitt Benckiser (UK) has now stopped the manufacturing of Nurofen Plus and its distribution has been halted across the UK.

Reckitt Benckiser, recalled the product on Friday night and halted distribution after discovering the issue. The firm estimated 250,000 packets were in customers’ hands.
Dr Aomesh Bhatt, medical director for Nurofen Plus said: “We are taking this matter extremely seriously and have decided to recall all packs of Nurofen Plus as the most prudent course of action in the current circumstances.”

The UK’s health authority, Medicines and Healthcare products Regulatory Agency (MHRA) has issued a class 1 drug alert to healthcare professionals, including General Practioners (GPs).
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by Erin A. Lawrence

sunscreen.jpgAfter 33 years of consideration, FDA finally plans to reduce consumer confusion related to the ample types of sunscreens available on the market. On Tuesday, June 14, FDA published new guidance that will specify which lotions provide the best protection against the sun.

The new rules require sunscreens that claim protection against skin cancer to prove that they filter out UVB and UVA rays. Currently, FDA only requires testing for UVB rays–the ultraviolet rays responsible for sunburn and cancer. UVA rays are responsible for wrinkles and cancer.

by Erin A. Lawrence

pills.jpgWhat would the world be like if we had the ability to determine our own illnesses without visiting a doctor? Well, a subsidiary of the Advanced Medical Technology Association, called AdvaMedDx, is looking to make genetic diagnostic tests available for use at home or in pharmacies and drugstores.

This technology would allow a consumer to self-diagnose and to choose over-the-counter (“OTC”) drugs that better meet their needs. AdvaMedDX’s ideas include kiosks at drug stores and pharmacies that are capable of analyzing a consumer’s saliva. Not only will such an advancement save time for the consumer, it will also likely lead to more drugs being OTC rather then prescription, because it would overcome concerns related to potential errors due to self-selection of medication. As recognized by Janet Woodcock, M.D., FDA Director of the Center for Drug Evaluation and Research, “The average consumer is not capable to determine whether they have [a certain] problem and then selecting an appropriate medication.”