The FDA – Help or Hindrance?

 
By Grant Clauser

Posted on: February 9, 2010

Every time a physician prescribes a drug or picks up a medical device and each time a patient walks into a doctor’s office with a request, somewhere in the background the Food and Drug Administration has left its mark. Sometimes the FDA is far in the background, sometimes right around the corner, but the agency is always there, symbolically at least, watching over (some might say lurking, while others would say supporting) the practice of medicine.

The FDA has a prominent role in the progression of the aesthetic dermatology market as the group that evaluates and approves new drugs and devices as well as monitors the marketing and messaging of those products. Over the past year the agency has impacted itself on the aesthetic field by approving several new injectable materials and devices, creating new opportunities for practitioners, while also taking a tough stand on companies for their marketing messages.

One of the biggest moves the FDA took recently was in May 2009 when the administration insisted on a black box  warning for Botox, a move which may have led some consumers to rethink that wrinkle treatment. Anytime you print “death” on an aesthetic drug, you’ll get people’s attention

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Will a Hydroquinone Ban Change the Cosmeceutical Market? Allergan again became a target of the FDA when in September it was accused of using misleading messages and materials in marketing the eyelash drug Latisse.

Then in October, Allergan sued the FDA over restrictions in marketing Botox for off-label use, claiming the FDA was infringing on its first amendment rights of free speech. In a New York Times article, Jeffrey N. Gibbs, a lawyer in Washington who specializes in food and drug law, was quoted saying: “This is the broadest attack on the constitutionality of FDA restrictions on speech brought by an individual drug company. It’s a precedent-setting case. They are seeking relief which would invalidate a number of the FDA regulations which restrict the promotion of drugs.”

Allergan hasn’t been the only aesthetic product company to have its messages scrutinized. In August the FDA sent a warning letter to Galderma over statements the company made on patient information for the promotion of bleaching drug Tri-Luma. The FDA called out Galderma for using visual aids that “recommend or suggest uses for Tri-Luma that have not been approved by FDA, and thus create new “intended uses” for the drug for which the product lacks adequate directions, broaden the indication for Tri-Luma, and omit and minimize important risk information for the drug.”

Doctors also occasionally catch the eye of the FDA for their role in industry. Most recently, dermatologist Leslie Baumann, MD, received an FDA warning regarding statements she made about the botulinum toxin Dysport to consumer beauty magazines prior to FDA approval and without acknowledging that she was an investigator in the drug’s clinical trials. (What are the larger implications of the FDA’s action against Dr. Baumann on dermatologists and plastic surgeons? Visit our Physician Forums to weigh in.)

Some of this increased scrutiny may be in response to the Obama administration’s call for more accountability in government. In an August 2009 speech, the president’s recently appointed FDA commissioner Margaret Hamburg, MD, noted that increased enforcement was going to be one of her top focuses. “Ultimately, an effective enforcement strategy creates public confidence in FDA oversight, which in turn keeps trust in the safety of FDA-regulated products from eroding. Such confidence is critical to the long-term interest of both consumers and industry,” she said.

In fact, last week the FDA requested an additional $4.3 billion for 2011 to enhance a number of initiatives including “FDA’s ability to act as a strong and smart regulator to address medical product safety.”

“The FDA has over the years prevented major problems within the United States,” says professor and chair of dermatology at the University of California Irvine Christopher B. Zachary, FRCP. “I applaud the FDA’s efforts. On the other hand, the government is not supplying sufficient resources for the enormous job it has to do,” he adds.

Kathy Fields, MD, a prominent California dermatologist also well known for cosmeceutical product lines Proactiv and Rodan +Fields, agrees that for all the FDA is trying to accomplish, the organization is tremendously backlogged.

“In the world of the FDA, there’s a tremendous amount of things to regulate and oftentimes the answers are not clear cut, so gaining the consensus required for action can cause extensive delays in implementation of important regulation,” she says. Among things experiencing such a delay are a monograph ruling on sunscreen SPF and UVA claims and a final decision on hydroquinone as topics important to dermatologists, Dr. Fields notes.

“Misinformation can take a wonderful ingredient and kill it.” says Dr. Fields. “We dermatologists have been waiting on the resolution for OTC accessibility of hydroquinone since 2006.” The ingredient was flagged in 2006 for a possible ban of over-the-counter sales. She worries that the result of inaction is a proliferation of misinformation–a not-uncommon problem in the aesthetics industry. At the 2009 meeting of the American Society for Dermatologic Surgery Fields presented a seminar to a packed room on the subject of controversial ingredients. 

510(k)

For as much scrutiny as the administration seems to be applying on drug makers and investigators, it’s still comparatively easy for a new medical device to receive approval. Most devices in the aesthetic industry are able to reach the market by way of a 510K premarket approval-a fairly simple process of proving that the new device in question is similar to an already approved device.

“It’s much easier to get a device approved than a drug,” says George Hruza, MD, clinical professor of dermatology at St Louis University. Dr. Hruza has been involved in several clinical trails in support of 510K clearances. “The company has to demonstrate to the FDA’s satisfaction that the device is at least as safe and effective as a pre-existing device on the market,” he explains. “That’s how almost all devices get their clearance.”

Hruza notes that for years, the FDA required little more than a letter from the manufacturer for the 510K clearance. However, he sees that changing. “The FDA has over the past couple of years tightened up on that and requests clinical data so you can demonstrate some efficacy.”

He says the process can still be “very vague” compared to drug trials that may involve thousands of patients.

What qualifies as efficacy in these cases? “Often it’s very minor,” says Dr. Hruza. “Historically they’ve [the FDA] been much more interested in safety, so in efficacy they were willing to accept very minor improvements.” Of course, efficacy often rests, particularly in the aesthetic market, as much in the hands of the practitioner as it does in the device itself. “There has been a definite shift toward asking for more demonstrated, reproducible and controlled data, so the data actually shows significant improvement,” he adds.

So what happens if the FDA pushes further and begins requiring significantly more data for 510K clearances. “When we get the devices we certainly want them to be effective,” notes Dr. Hruza. “But if the FDA puts up too many hurdles to get devices approved, then it gets very expensive and difficult. Most of the companies don’t have the resources. So it’s a mixed bag–there may be fewer devices that make it to market because it’s too expensive.”

That scenario could mean less innovation and less physician and patient choice.

Dr. Zachary believes device approval should be removed from the FDA’s responsibility altogether and placed in the hands of industry. “I would argue that much of the current approval process should be shifted to an independent group similar to the UL [Underwriter's Laboratories] which would be funded by the pharmaceutical and device companies. If the administration really wants to improve the process, they need to think outside the box. The U.S. tort system would provide a counter balance to such an independent system, as it does for any other consumer product such as a hair dryer or automobile.”

Drug vs. Cosmetic

One area where the FDA is not taking a particularly hard line these days is regulation of cosmetics. If a product doesn’t make changes to the skin, it’s a cosmetic. If it does, it’s a drug. The problem is that the line between the two, and how they’re marketed, is very blurry.

“Now you have new delivery vehicles,” says Dr. Fields. “You’re taking something that may have been just a cosmetic and you’re driving it in deep and making changes. Some are penetrating.” The FDA maintains a vague definition of a cosmetic as something for promoting attractiveness or alternating appearance while a drug treats disease or affects the structure or function of the body. Dr. Fields contends that the FDA’s position comes down to semantics. If a product seems to be crossing the line “they’ll tell you to back off on your [result] claims.”

Aside from a banned ingredients list, there isn’t much regulation of the cosmetic, cosmeceutical or nutraceutical market. On the one hand this fuzzy approach may make it easier for consumers to get effective products. On the other, consumers may not really know what they’re getting.

The situation may be changing, at least for the nutraceutical or supplement market. Last week Senator John McCain held a press conference in support of the Dietary Supplement Act of 2010 which proposes the FDA get significantly more oversight powers of supplements. “The legislation would require dietary supplement manufacturers to register with the FDA and fully disclose the ingredients contained in the supplement,” he stated. He also called for the FDA to receive mandatory recall authority over supplements, citing ten years it took to ban ephedra (an ingredient believed to have caused the death of several athletes) as an example of why such authority is needed.

Two supplement trade organizations, the Natural Products Association and the Council for Responsible Nutrition, both came out with statements opposing some portions of the act and encouraging better enforcement of existing regulations, rather than burden the FDA with new ones.

Freedom to Practice

So should strict scrutiny by the FDA give physicians confidence that the devices or drugs they’re using on their patients have been subject to close inspection, or does it constrain the industry, preventing physicians from practicing their professional judgment? The answer may be a little of both.  

This question is particularly pertinent when it comes to the question of off-label uses. The FDA spends a lot of time going after manufacturers for promoting off-label uses of drugs or devices, while physicians are free to use the products for the purpose they feel is justified. For example, long before Sculptra was approved as a cosmetic filler for nasolabial folds, physicians were using it for that. Botox Cosmetic is approved for injecting into the glabellar lines, but physicians are currently injecting in a multitude of other ways–and discussing those ways openly in publications and medical conventions. The manufacture, Allergan, is unable to acknowledge that, hence the suit noted earlier. In last week’s New York Times, an article acknowledges that many physicians are employing products like Zerona and Zeltique for uses the products are not specifically approved for.

“There is a well established understanding in the U.S. that physicians can use drugs and devices off-label. As long as the FDA has approved Aspirin for one thing, a physician can use it for another indication. This makes sense. If not, we’d be in a pretty mess,” says Dr. Zachary. “Making a medical decision is all about judgment and experience. You have to individualize the treatment of a patient. We all went to medical school, and we all specialize for a reason. That’s not to be confounded by some government administration. I’m actually quite shocked that the medical profession is being so meek and so accepting of knee jerk legislation that costs a fortune and has little evidence of benefit.”

On the whole, Dr. Zachary would like to see health care regulation by the government scaled back dramatically. “The costs of health care regulation are approximately $360 billion, and only half of these regulations actually provide any benefit for the patients. The authors of these useless regulations should be held accountable because they are making U.S. healthcare unaffordable,” he argues.

With all the contention and conflicts this topic brings up, everyone contacted for this article agrees that there needs to be a body overseeing the safety of products physicians and consumers put their faith in. Careers and lives are on the line. Does the FDA need to do more in some areas and less in others? That debate could fill up an entire medical conference as could questions of resource allocation and agenda.

In the end, the FDA is an important part and partner of the aesthetics industry and working cooperatively has the greatest potential for positive outcomes. “I think it’s important to have a watchdog situation where both the FDA is paying attention and dermatologists are paying attention,” says Dr. Fields.

Grant Clauser is editor of Healthy Aging.

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