Tag: FDA

Social Media, Twitter and FDA Guidance

Social Media, Twitter and FDA Guidances-Prescription Drugs and Medical Devices

FDA just released on June 17 two important draft Guidances for the FDA regulated industry specific to prescription human and animal drugs and medical devices for humans.
Guidance for Industry Internet/Social Media Platforms with Character Space Limitations— Presenting Risk and Benefit Information for Prescription Drugs and Medical Devices
The first draft guidance describes how manufacturers, packers and distributors of prescription drugs and devices should present both benefit and risk information within advertising and promotional labeling on electronic and digital platforms that have character space imitations such as Twitter,  on the Internet,  social media and or other hi-tech settings.
Major Points Articulated by FDA:
Benefit information should be accurate and non-misleading and reveal material facts within each individual character-space-limited communication (e.g., each individual message or tweet).
Benefit information should be accompanied by risk information within each individual character-space-limited communication.
If a firm concludes that adequate benefit and risk information, as well as other required information, cannot all be communicated within the same character-space-limited communication, then the firm should reconsider using that platform for the intended promotional message.
Character Space Limitations such as Twitter:
Risk information should be presented together with benefit information within each individual character-space-limited communication (e.g., each individual message or tweet); The content of risk information presented within each individual character-space-limited communication should, at a minimum, include the most serious risks associated with the product.
A mechanism, such as a hyperlink, should also be provided within each individual character- space-limited communication to allow direct access to a more complete discussion of risk information about the product.
The prominence of risk information should be comparable to the benefit information within each individual character-space-limited communication, taking into consideration any formatting capabilities available on the specific Internet/social media platform.

Guidance: Internet/Social Media Platforms: Correcting Independent Third-Party Misinformation About Prescription Drugs and Medical Devices

The second draft guidance details how prescription drug and device manufacturers, packers, and distributors should respond, if they choose to do so, to misinformation generated  and distributed by independent third parties on the Internet or through social media avenues.According to FDA appropriate corrective action by a company should:

  • Be relevant and responsive to the misinformation;
  • Be limited and tailored to the misinformation;
  • Be non-promotional in nature, tone, and presentation;
  • Be accurate;
  • Be consistent with the FDA-required labeling for the product;
  •  Be supported by sufficient evidence, including substantial evidence, when appropriate, for prescription drugs;
  • Either be posted in conjunction with the misinformation in the same area or forum (if posted directly to the forum by the firm), or should reference the misinformation and be intended to be posted in conjunction with the misinformation (if provided to the forum operator or author); and
  • Disclose that the person providing the corrective information is affiliated with the firm that manufactures, packs, or distributes the product.

The direct links are as follows:

Benefit:

These two important guidances, although in draft format, provide the regulated industry with a more descriptive concept of  FDA expectations. Although not legally binding, these draft guidances, unlike previous drafts specific to these issues, provide more direction and clarity to the regulated industry.

POM WONDERFUL LLC v. COCA-COLA CO.

POM WONDERFUL LLC v. COCA-COLA CO.

United States Supreme Court Holding: A competitor may bring a Lanham Act claim(s) that alleges unfair competition from false or misleading labels on food and beverage labels regulated under the United States Federal Food, Drug and Cosmetic Act.
Link to Supreme Court opinion is below.
http://www.supremecourt.gov/opinions/13pdf/12-761_6k47.pdf

Practice of Medicine or Drug Biologic Product—Regenerative Sciences, LLC

“Practice of Medicine” or FDA Authority to Regulate

The Food and Drug Administration and the Authority to Regulate

USA v Regenerative Sciences

Regenerative Sciences, LLC vigorously defended its position that FDA could not regulate the practice of medicine in its Regenexx™ treatment or Regenexx-C™ cultured treatment which uses Mesenchymal adult stem cells (MSCs) that originate primarily from bone marrow. The company promotes the Regenexx™ treatment as a “non-surgical” treatment option for joint or bone pain in the hip, knee, shoulder, back or ankle as well as non-union fractures. The dispute with FDA has been ongoing since at least 2008 when FDA sent correspondence to Regenerative Sciences depicting the cell treatment as a drug or biologic. FDA conducted an inspection and found violations of current Good Manufacturing Practices (cGMPs). The United States Court of Appeals for the District of Columbia Circuit upheld the District Court and the United States Food and Drug Administration’s (FDA’s) argument that Regenerative Sciences “Cultured Regenexx Procedure” was a biological drug subject to FDA approval through the biologics licensing application (BLA) process. The court of appeals upheld the permanent injunction against the use of the biological drug without FDA approval. The issue focused on the practice of medicine versus the regulation by the United States Food and Drug Administration. This distinction has far reaching ramifications. 

Issue the Court of Appeals Addressed

In the civil enforcement action, the court of appeals had to decide “whether the appellants—three individuals and a related corporate entity—violated federal laws regulating the manufacture and labeling of drugs and biological products by producing, as part of their medical practice, a substance consisting of a mixture of a patient’s stem cells and the antibiotic doxycycline.” The court of appeals determined that FDA had the authority to regulate the product and affirmed the district court’s judgment and the permanent injunction it entered against appellants.

What Regenerative Sciences, LLC Argued

Regenerative Sciences, LLC (Regenerative Sciences) alleged several arguments that their product did not fall within FDA regulatory authority; however, the court rejected all of the arguments. For example, Regenerative argued that the Federal Food, Drug, and Cosmetic Act (FDCA) did not apply because the product was a procedure overseen by state “practice of medicine”. Another argument advanced by Regenerative Sciences was that the product was exempt from FDA approval because it was a compounded product and further it was a minimally manipulated product. As mentioned, the court of appeals rejected all of the arguments advanced by Regenerative Sciences.

Looking Ahead

This was a long awaited decision. The future is uncertain in terms of how a court will rule about novel therapies such as the issue in this case. However, no doubt as more technological advances occur, FDA will again be challenged as to the agency’s authority to regulate such products and or procedures.The link to the full case is as follows:

USA v Regenerative Sciences

FDA’s Lucky 13

FDA’s Lucky 13 and Why We Need the United States Federal Food and Drug Administration

Decorative Contact Lenses, Temporary Tattoos, Novelty Makeup, Food Safety and more…

This blog is less formal than usual-yet still provides key information and demonstrates “why” the United States public still needs the United States Federal Food and Drug Administration. Many in the United States celebrate Halloween in high fashion and FDA is right in step. FDA launched an informative website titled:

‘Lucky 13’ Tips for a Safe HalloweenThe information applies to products regulated in the personal care area, medical device arena, foods, novelty-makeup and color additives.http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm230283.htm

Decorative Contact Lenses— Decorative Contact Lenses: Is Your Vision Worth It? 

A word about decorative contact lenses and a link.  Here is what FDA recommends. http://www.fda.gov/downloads/ForConsumers/ConsuperUpdates/ucm275184.pdf 

Here is just a capsule of FDA recommendations.

Get an eye exam from a licensed eye doctor (ophthalmologist or optometrist), even if you feel your vision is perfect.

Get a valid prescription that includes the brand name, lens measurements, and an expiration date. But don’t expect your eye doctor to prescribe anime, or circle, lenses. These bigger-than-normal lenses that give the wearer a wide-eyed, doll-like look have not been approved by FDA.

Buy the lenses from a seller that requires you to provide a prescription, whether you go in person or shop online.

Novelty Make-up-Think you have it covered.

Well think again and take a look at what FDA thinks.

 http://1.usa.gov/2XHDVa

Temporary Tattoos 

Temporary tattoos are not necessarily safe and are not necessarily regulated as strongly as one might assume. http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm343932.htm

This capsule view succinctly demonstrates “the why” of FDA.

Summer is Here and so is the Sunscreen Rule

sunThe Sunscreen Rule Update

Now that summer is upon us, here is a summary of the sunscreen rule. Have you seen claims on sunscreen labeling such as “waterproof” or “sweatproof”, or identify their products as “sunblocks”? Well, those terms cannot be used anymore. However, the compliance date for those companies with annual sales of less than $25,000 was delayed until December 17, 2013. Here are key aspects of this rule.

Standard Test

Establishes a standard test for over-the-counter sunscreen products that will determine which products are allowed to be labeled as “Broad Spectrum. Products that pass this test will provide protection against both ultraviolet B radiation (UVB) and ultraviolet A radiation (UVA).

Front Labeling: Under the new regulations, sunscreen products that protect against all types of sun-induced skin damage are labeled “Broad Spectrum” and “SPF 15” (or higher) on the front. Back Labeling: Informs consumers on the back of the product that sunscreens labeled as both “Broad Spectrum” and “SPF 15” (or higher) not only protect against sunburn, but, if used as directed with other sun protection measures, can reduce the risk of skin cancer and early skin aging. For these broad spectrum products, higher SPF (Sun Protection Factor) values also indicate higher levels of overall protection. By contrast, any sunscreen not labeled as “Broad Spectrum” or that has an SPF value between 2 and 14, has only been shown to help prevent sunburn.

Warning Statement: Sunscreen products that are not broad spectrum or that are broad spectrum with SPF values from 2 to14 must be labeled with a warning that reads: “Skin Cancer/Skin Aging Alert: Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to help prevent sunburn, not skin cancer or early skin aging.”

Claims

Water resistance claims on the product’s front label must tell how much time a user can expect to get the declared SPF level of protection while swimming or sweating, based on standard testing. Two times are permitted on labels: 40 minutes or 80 minutes. Manufacturers cannot make claims that sunscreens are “waterproof” or “sweatproof, or identify their products as “sunblocks.”   In addition, sunscreens cannot claim protection immediately on application (for example, “instant protection”) or protection for more than two hours without reapplication, unless they submit data and get FDA approval.http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm258416.htm

Delay Does not Protect the Ultimate User

Although the Sunscreen Rule was issued June 9, 2011with a compliance date of June 18, 2012, it was delayed until December 17, 2012. Further, the compliance date for those companies with annual sales of less than $25,000 was delayed until December 17, 2013.

What else is on the “Sunscreen Horizon”?

Sun Sprays 

An Advanced Notice of Rule Making was issued at the same time as the “Sunscreen Rule”. The Notice concerns a data request for safety and effectiveness information for sunscreen products formulated in certain dosage forms (e.g., sprays).

50+ Is there any Benefit to the 50+ Sunscreens?

FDA proposed a regulation that would limit the maximum SPF value on sunscreen labeling to “SPF 50+”. The FDA proposed Rule sets forth that the maximum labeled SPF value for over the counter (OTC) sunscreen products would be “50&plus”. The proposed rule comes after a data review showed that there is not currently sufficient data to indicate that there is additional clinical benefit above SPF 50. There was not adequate data that demonstrated that a sunscreen product with an SPF value over 50 provided an increase in clinical benefit over a sunscreen product with an SPF value of over 50.

Conclusion

As with other FDA regulation, time will tell if 50+ will be permitted as well as the effectiveness of sprays. Based on prior regulatory efforts that time could continue for years without a settled regulation.

Labeling and Effectiveness Testing; Sunscreen Drug Products for Over-the-Counter Human Use 21 CFR Parts 201 and 310

The Little Red Wine Pill Panacea

Red Wine or a Red Pill

Several years ago- the old adage “an apple a day keeps the doctor away” was tweaked for adults to “a glass of red wine a day keeps the heart healthy”.  The push to drink red wine for purported medical benefits such as heart health became all the rage. http://www.foxnews.com/health/2012/05/21/red-wine-healthy-elixir-or-lot-hype/

Until recently, there was not as much a push to do this. However, the spotlight on the purported medicinal benefits of red wine has become in the forefront again. It appears that there may be other benefits related to aging. See: New Study Validates Longevity Pathway. http://hms.harvard.edu/news/new-study-validates-longevity-pathway-3-7-13 The article discusses a recent revelation that Dr. David Sinclair and his team of researchers found concerning resveratrol and SIRT1. Resveratrol is a compound found in the skin of grapes and berries and also peanuts and it is supposed to increase the activity of sirtuin, SIRT1.  Simply stated, the increased SIRT1 activity shields the body from diseases due to accelerating the mitochondria which normally slows as one ages. According to Dr. Sinclair, Harvard Medical School professor of genetics and senior author, “In the history of pharmaceuticals, there has never been a drug that binds to a protein to make it run faster in the way that resveratrol activates SIRT1”.

How would the Red Pill be Regulated?

It this too good to be true and if it is true how should the “red pill” be regulated?  How would the product be classified—dietary supplement, over the counter pharmaceutical or prescription drug? Wouldn’t drinking a glass of wine suffice? According to a recent report, one would have to drink 100 glasses of wine for any medical benefits to occur.

Classification of the product is important in terms of how the United States Food and Drug Administration would regulate this product. If regulated as a dietary supplement pre-approval is not a requisite. If regulated as a prescription drug, then a New Application would have to be filed with the United States Food and Drug Administration (FDA). The Drug Approval process is time consuming and arduous. Yet, shouldn’t it be arduous when human safety issues are involved?

Who Would Have the Authority to Regulate An “Enriched Wine”?

Suppose wine could be “enriched” to provide medical benefits. Jurisdiction become tricky too. Jurisdiction under this scenario is a legal term of art that refers to the proper government entity that has the authority to regulate.  How is wine regulated and who has the authority to regulate red wine? Is it the United States Department of Treasury, Alcohol, Tobacco, Tax and Trade Bureau (BATT)? Actually, BATT oversees alcoholic beverage regulation except wine beverages containing less than 7 percent alcohol, which are under the jurisdiction of FDA. BATT enforces laws that govern the production and distribution of alcoholic beverages and investigates adulterated alcoholic products with FDA assistance.

Recommendations

To date, the research seems promising and there may be medical benefits yet it appears that more research is needed. The current information and research is not yet definitive as to whether the product would even “work” or be beneficial. The reality is that more research is needed. As much as one can extol the myriad benefits of taking the “little red pill” or drinking red wine (100 glasses?) prudence is recommended. In the meantime, enjoy your red wine for what it is.

The What and Why of Pharmacy Compounding

Pills

What is Pharmacy Compounding?

Pharmacy compounding usually involves a small quantity of custom made prescriptions. However, this has changed over the years to what some term large scale production. By way of illustration, in the later part of 2012, the United States Food and Drug Administration (FDA) was forced to confront the issue of pharmacy compounding on a large scale. This was due to several deaths associated with compounded drug products linked to fungal meningitis that involved the New England Compounding Center (NECC). FDA Commissioner Margaret Hamburg testified before Congress and specifically recommended that Congress enact legislation to provide authority FDA with enforcement authority. The NECC distributed contaminated pain injections that caused serious adverse events including approximately 32 deaths.

Why did this happen?

Well back in 2002, an FDA inspection revealed a contamination issue with the same steroid; however, FDA had to defer to Massachusetts state authorities. Traditionally, with pharmacy compounding, state pharmacy boards maintain regulatory oversight. Further, as mentioned, traditionally compounding pharmacies fill special orders from physicians for an individual patient. Yet, over the years, this has changed dramatically from a small to large-scale operation and NECC is an illustration of where thousands of doses of drugs were shipped to several states.

What are the FDA Solutions?

Commissioner Hamburg proposed a two-tier system in which traditional compounding pharmacies continue to be regulated at the state level, and larger pharmacies would be subject to FDA oversight. According to Dr. Hamburg, these non-traditional pharmacies that operate on large-scale compounding would have to register with the FDA as well as undergo regular inspections. Further, these large-scale compounding pharmacies would be obligated to meet the more rigorous manufacturing standards required of pharmaceutical companies.
Previously, FDA attempts to regulate large scale operations have been stymied; however, that should change. For example, Ameridose LLC, managed by the same parties who managed NECC, voluntarily recalled all of its unexpired products in 2012 due to FDA sterility assurance concerns. The recall was conducted for preventive measures not because of reports of adverse events such as infections.

As background, when the United States Supreme Court decision of Thompson v. Western States, was decided back in 2002, FDA then clarified that the agency would continue to use enforcement action against those who compounded drugs that are actually attempts to illegally manufacture drugs. FDA released a Compliance Policy Guide (CPG) section 460.200 [Pharmacy Compounding] issued by FDA on May 29, 2002, following the Thompson Supreme Court decision. The CPG sets forth a list of factors that FDA considers in determining whether to take enforcement action when the scope and nature of a pharmacy’s activities raise the kind of concerns ordinarily associated with drug manufacturing. For example, FDA would consider enforcement action against pharmacists who compound medications that are commercially available in the marketplace or those that use bulk ingredients that are not components of FDA approved drugs or those pharmacists who use commercial scale manufacturing or testing equipment.

Recommendations

Here is what I propose. The tier proposal is a good start. Yet, what really needs to happen is communication on all levels. By that I mean communication with state and federal government agencies as well as communication between industry and the FDA as well as state pharmacies. Finally, the nature of pharmacy compounding has markedly changed from small to large scale manufacture. So, the time is ripe for Congress to address this issue legislatively.

Stay tuned for more on pharmacy compounding specific to veterinary products.