Prison Sentences- Peanut Corp.of America Salmonella Tainted Peanut Products

Update-Sentences Affirmed on January 23, 2018 Corp. Executive Liability Sentence Largest Ever in Food Safety History 

AFFIRMED:  See: United States v. Parnell, et. al, No. 15-14400 (11th Cir. Jan. 23, 2018)  Click on the link for the appellate court decision. Court of Appeals Opinion

Former Peanut Corporation of America (PCA) President and Owner Stewart Parnell received a criminal prison sentence of 28 years in connection with the 2009 salmonella poisoning outbreak of 700 reported cases in 46 states. Expert evidence presented at trial detailed that there were nine deaths linked to PCAs tainted products. Parnell’s brother Michael received a 20 year prison sentence. The Quality Assurance employee received a 5 year sentence. They were sentenced based on their roles at PCA by shipping salmonella-positive peanut products and by falsifying microbiological test results.  A federal jury convicted the Parnell brothers in September 2014 on several counts of conspiracy, mail and wire fraud as well as selling misbranded food. Stewart Parnell was also convicted for introducing adulterated food into interstate commerce.  Stewart Parnell and Quality Assurance Manager Mary Wilkerson were also convicted of obstruction of justice. According to U. S. Justice Attorney Moore, “The sentence that was handed down today [Sept. 21, 2015] means that executives will no longer be able to hide behind the corporate veil”. The direct link to the sentences in the Parnell Salmonella Tainted Peanut Product case is below and court of appeals opinion above.

AFFIRMED:  See: United States v. Parnell, et. al, No. 15-14400 (11th Cir. Jan. 23, 2018 (affirmed)). Click on the link Court of Appeals Opinion

http://www.justice.gov/opa/pr/former-peanut-company-president-receives-largest-criminal-sentence-food-safety-case-two

Top 5 Accomplishments— FDA Year in Review and Wish List!

Year in Review—Top 5 (well more than 5) Highlights of FDA Accomplishments and FTC in 2014.  Here are just a few top accomplishments in food and drug law in 2014. Last year, the question posed was whether the United States really needs an “FDA”. The role and mission of FDA has been debated for years.  The FDA role ranges from that of a regulator, watchdog and facilitator. Commentary ranges from overbearing federal regulation to lack of public protection. Yet, based on these selected accomplishments, FDA provides an important function in keeping with the mission of the Food, Drug and Cosmetic Act and the numerous amendments. Although the FDA has across the board accomplishments, the following are standouts and all involve safety—Ebola, Power Morcellators,  Food Safety Modernization Act Supplemental Proposed Rules, Tobacco Enforcement, Calorie Disclosure Rules, Criminal Liability, Sunscreen Innovation Act and Diet Products….just to name a few. 

CAFFEINE-INFUSED SHAPEWEAR

Norm Thompson Outfitters and Wacoal America Settle FTC Charges Over Weight-Loss Claims The Federal Trade Commission approved two final orders settling charges that two companies, Norm Thompson Outfitters. Inc., and Wacoal America, Inc., misled consumers regarding the ability of their caffeine-infused shapewear undergarments to reshape the wearer’s body and reduce cellulite. According to the FTC’s complaints, the two companies’ marketing claims for their caffeine-infused products were false and not substantiated by scientific evidence. The products, made with Lytess brand fabrics, were sold via mail order and on the company’s Norm Thompson Outfitters, Sahalie, Body Solutions, and Body Belle websites. FTC alleged that the company made claims that wearing its shapewear would eliminate or substantially reduce cellulite; reduce the wearer’s hip measurements by up to two inches and their thigh measurements by one inch; and reduce thigh and hip measurements “without any effort.” The complaint against Wacoal America contained similar allegations. It charged that the company’s iPants supposedly slimmed the body and reduced cellulite. Specifically, the company made false and unsubstantiated claims that wearing iPants would: substantially reduce cellulite; cause a substantial reduction in the wearer’s thigh measurements; and destroy fat cells, resulting in substantial slimming. http://www.ftc.gov/enforcement/cases-proceedings/132-3095/wacoal-america-inc-matter

EBOLA OUTBREAK 

Currently, the standard treatment for patients infected with the Ebola virus is supportive therapy. However, that could change in the near future. NIH reported in late 2014 that an experimental vaccine to prevent Ebola virus disease proved successful in phase I clinical trial in all 20 healthy adults who received it. The vaccine is being developed by the NIH’s National Institute of Allergy and Infectious Diseases and GlaxoSmithKline. Expedited review is in the works for the priority review track as well as immunity protection.The experimental drug ZMapp was used in 2014 to treat a few patients infected with Ebola; however, it is still uncertain to ascertain the effectiveness of ZMapp. According to the manufacturer, the product is in the experimental stages and clinical trials are needed. Besides Mapp Biopharmaceutical Inc., Tekmira, Chimerix and BioCryst Pharmaceuticals have therapeutic products in early developmental stages for clinical trials. See: Peter Loftus and Betsy McKay, Race is On for Ebola Drug, All St. J. A1 (Oct. 18-19 2014); Betsy McKay and Peter Loftus, Wall St. J. A7 Experimental Drugs Are Approved for Use in Fighting Ebola in West Africa (Aug. 13, 2014);http://www.cdc.gov/vhf/ebola/outbreaks/guinea/qa-experimental-treatments.html

http://www.nytimes.com/2014/08/07/business/an-obscure-biotech-firm-hurries-ebola-treatment.html

http://www.washingtonpost.com/blogs/monkey-cage/wp/2014/08/06/ebola-research-ethics-and-the-zmapp-serum/

POWER MORCELLATORS—Warning and Immediate Guidance

Laparoscopic Uterine Power Morcellation: Immediately in Effect Guidance Document: Product Labeling for Laparoscopic Power Morcellators; Guidance for Industry and Food and Drug Administration Staff  http://www.gpo.gov/fdsys/pkg/FR-2014-11-25/html/2014-27857.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery

Laparoscopic Uterine Power Morcellation in Hysterectomy and Myomectomy: FDA Safety Communication http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm424443.htm

CRIMINAL FELONY CONVICTIONS 

Corporate Executive Liability Food Safety—Felony Conviction Peanut Corporation of America Background and Corporate Significance The former owner of Peanut Corporation of America Peanut Corp.) Stewart Parnell was convicted on September 19, 2014 of conspiracy and other charges in connection with a deadly salmonella outbreak that occurred in 2008-2009. According to the Centers for Disease Control and Prevention, nine people died and over 700 others became ill in 2008-09 after eating peanut butter or other products prepared at the company’s plant in Georgia. Mr. Parnell, was found guilty on several counts, including wire fraud and obstruction of justice. The indictment was centered on a conspiracy to conceal that several of Peanut Corp.’s products were contaminated with salmonella. Others involved and convicted included the brother of Stewart Parnell, Michael Parnell, a food broker who worked on behalf of Peanut Corp. and the quality assurance manager, Mary Wilkerson, for obstruction of justice. Two other former Peanut Corp. employees has previously pled guilty to multiple charges. Prosecutors alleged that Peanut Corp. not only defrauded customers but also defrauded several national food companies by failing to inform them about the presence of food-borne pathogens in laboratory tests, including salmonella. According to prosecutors, in some instances, despite these results, Peanut Corp. officials totally falsified lab results, maintaining peanut products were safe for consumption. Further, at times, the Peanut Corp. failed to even perform testing. Although for years, corporate executives have been charged with misdemeanor offenses under the strict criminal liability theory known as the Park doctrine, this case is distinguishable. The Peanut Corp. case represents a felony prosecution under the Federal Food, Drug and Cosmetic Act. The Peanut Corp. prosecution serves as a wake up call to the regulated food safety industry.

CALORIE DISCLOSURE FINAL RULES

Vending Machines and Restaurant Menu Labeling Overview and link to final rules. http://www.fda.gov/Food/IngredientsPackagingLabeling/LabelingNutrition/ucm248732.htm

Introduction and Quick Summary FDA released the long awaited two final rules in early December (2014) regarding caloric disclosure The rules were proposed in April 2011 under section 4205 of the Affordable Care Act. The final rule is effective date is December 1, 2015 to afford vending machine operators and affected restaurants time to comply. The final rule summaries issued by FDA are below as well as a direct link and issue to consider.  Food Labeling; Calorie Labeling of Articles of Food in Vending Machines Requires operators who own or operate 20 or more vending machines to disclose calorie information for food sold from vending machines, subject to certain exemption.   

Food Labeling; Nutrition Labeling of Standard Menu Items in Restaurants and Similar Retail Food Establishments Applies to restaurants and similar retail food establishments if they are part of a chain of 20 or more locations, doing business under the same name, offering for sale substantially the same menu items and offering for sale restaurant-type foods.

TOBACCO ENFORCMENT 

 Tobacco products are regulated so differently than other FDA regulated products due to the fact they are harmful yet still extensively used consumer products and are responsible for severe health problems in both users and non-users, including cancer, lung disease, and heart disease, which often lead to death. The focus remains on youth and the FDA is faced for 2015 with the Ecigarette issue and deeming. CTP established the Office of Compliance and Enforcement (OCE); however, enforcement is limited as FDA’s regulatory authority is dictated by the FSPTCP. CTP has filed actions for civil monetary penalties mainly for sales to minors. A Civil Money Penalty (CMP) Complaint is used to initiate an administrative legal action against a retailer that can result in the imposition of a fine, termed a Civil Money Penalty. As an example of enforcement efforts, FDA filed approximately 100 civil legal actions. FDA recently sent warning letters to retailers for selling to minors. Here is the direct link:

http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/Tobacco/ucm424581.htm

FOOD SAFETY

Food Safety Modernization Act Supplemental Proposed Rules: Did you know that much of the food that Americans consume originate from countries outside of the United States? The Food Safety Modernization Act (FSMA), signed into law back in January 2011, addresses imported food as well as food produced in the United States. Several proposed rules were issued in 2013 and now in 2014 supplemental proposed rules. Here is the direct link to the final and proposed rules.

http://www.fda.gov/Food/GuidanceRegulation/FSMA/ucm253380.htm

SUNSCREEN INNOVATION ACT

Finally, the Sunscreen Innovation Act (SIA), recently signed into law in late 2014, (Public Law No: 113-195 Nov. 26, 2014) establishes a new process for the review and approval of over-the-counter sunscreen active ingredients. The SIA provides FDA with explicit, expedited deadlines for review. The SIA is a major improvement as for example some sunscreen ingredients have been under review for over ten years. Direct Link to SIA is as follows: https://www.congress.gov/bill/113th-congress/senate-bill/2141/text

WISH LISTS

FDA WISH LIST—Congressional Authorization of more resources, i.e. MONEY so FDA can effectively fulfill the mission of the FDCA. 

STAKEHOLDER WISH LIST—More Clarity from FDA!

RECOMMENDATIONS—FDA and the FTC did have major accomplishments as the above examples illustrate. They illustrate the necessity for “an FDA” as well as an “FTC”. Hopefully though the proposed rules will be finalized in 2015 and hopefully Congress will revisit FDA regulatory authority for some products such as dietary supplements where FDA can only legally exercise post-enforcement. Stay tuned for more about the role of FDA and for more food and drug law updates in 2015.

Seizure and Consent Decree Unapproved Pharmaceuticals

Ascend Laboratories…Seizure and Consent Decree

The following is a recent FDA issued press release about Ascend Laboratories, LLC.  The court for the South District of Ohio entered the consent decree for permanent injunction against Ascend Laboratories, LLC. Besides the seizure action, the company is enjoined from manufacturing and distributing unapproved drugs until Ascend obtains approval from FDA. The action was based on inspections which revealed that the company was manufacturing approved drugs.

http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm418867.htm

Federal judge approves FDA consent decree with Ascend Laboratories 

For Immediate Release: October 14, 2014 A federal judge from the U.S. District Court for the Southern District of Ohio entered a consent decree for permanent injunction against Ascend Laboratories, LLC, of Montvale, New Jersey on Oct. 10. The U.S. Department of Justice filed the consent decree on behalf of the U.S. Food and Drug Administration.

The consent decree requires Ascend Laboratories to post bond for the release of their unapproved drug products seized by U.S. Marshals in May 2014, which the company is then responsible for destroying under the FDA’s supervision. The drugs were seized at a warehouse in Cincinnati operated by Masters Pharmaceutical, Inc. (doing business as RXTPL).

In addition, the consent decree prohibits Ascend Laboratories and all other associated persons who act in concert with the company from manufacturing and distributing unapproved drugs until the company obtains FDA approval, including: Pramoxine-HC Otic Drops; Hydrocortisone Acetate Suppositories 25 milligrams; Urea Cream 39%; Urea Cream 40%; and Urea Lotion 40%.

“Manufacturing and distributing unapproved prescription drugs puts patients’ health at risk since they have not been found to be safe, effective or made using quality manufacturing practices,” said Ilisa Bernstein, acting director of the Office of Compliance in the FDA’s Center for Drug Evaluation and Research. “Companies that fall short of our requirements risk FDA action to stop the distribution of their products.”

The FDA inspected Ascend Laboratories’ New Jersey facility in November 2013 and Masters Pharmaceutical’s Cincinnati warehouse in February 2014. The inspections revealed that Ascend Laboratories was marketing drug products without FDA approval and adequate directions for use.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

Corporate Accountability Food Safety Felony Conviction

Corporate Executive Liability Food Safety—Felony Conviction

Peanut Corporation of America Background

The former owner of Peanut Corporation of America Peanut Corp.) Stewart Parnell was convicted on September 19, 2014 of conspiracy and other charges in connection with a deadly salmonella outbreak that occurred in 2008-2009. According to the Centers for Disease Control and Prevention, nine people died and over 700 others became ill in 2008-09 after eating peanut butter or other products prepared at the company’s plant in Georgia. Mr. Parnell, was found guilty on several counts, including wire fraud and obstruction of justice. The indictment was centered on a conspiracy to conceal that several of Peanut Corp.’s products were contaminated with salmonella. Others involved and convicted included the brother of Stewart Parnell, Michael Parnell, a food broker who worked on behalf of Peanut Corp. and the quality assurance manager, Mary Wilkerson, for obstruction of justice. Two other former Peanut Corp. employees has previously pled guilty to multiple charges.

Prosecutors alleged that Peanut Corp. not only defrauded customers but also defrauded several national food companies by failing to inform them about the presence of food-borne pathogens in laboratory tests, including salmonella. According to prosecutors, in some instances, despite these results, Peanut Corp. officials totally falsified lab results, maintaining peanut products were safe for consumption. Further, at times, the Peanut Corp. failed to even perform testing.

Corporate Liability Significance

Although for years, corporate executives have been charged with misdemeanor offenses under the strict criminal liability theory known as the Park doctrine, this case is distinguishable. The Peanut Corp. case represents a felony prosecution under the Federal Food, Drug and Cosmetic Act. The Peanut Corp. prosecution serves as a wake up call to the regulated food safety industry.

Outcome and Sentencing

Peanut Corp. filed for Chapter 7 bankruptcy protection weeks after the outbreak began. The felony convictions mean the possibility of a extensive prison sentence and fines.

Is Your FDA Regulated Product a Drug, Device or Combination?

Prevor v. United States Food and Drug Administration

Primary Mode of Action Determination is Critical in Combination Product

Introduction: At times, the United States Food and Drug Administration struggles with proper product classification. The case of Prevor v. Food and Drug Administration , D.D.C., No. 1:13-cv-01177 (September 9, 2014) provides a prime example. The major complex issue is whether the product should be classified as a drug, medical device or combination.

About the Product: The form of Diphoterine® Skin Wash (DSW) is a liquid substance in a canister propelled by pressurized gas. Intent is critical in the determination of product classification.

Background:  The drug, device and combination product classification issues stem back to 2009. Originally, back in 2009, FDA’s Office of Combination Products classified Prevor’s skin wash product, DSW as a drug primary mode of action rather than as a device as a primary mode of action. See 21 C.F.R. § 3.2(m).  FDA found the product had two primary intended purposes using the reasoning “to wash the chemical off the skin and neutralize the chemical that is on the skin.”

Prevor I: In 2012, the District Court found the FDA’s action classifying the DSW product as a drug primary mode rather than a device as a primary mode was both arbitrary and capricious.  The District Court vacated the FDA’s decision to classify  DSW as a drug-device combination product with a “drug” primary mode of action.  Yet, Prevor, a device maker,  has vigorously argued that the product is a device and not a drug. Alternatively, if deemed  a combination product, the primary mode of action according to Prevor would be a device. Prevor v. Food and Drug Administration (Prevor I ), 895 F.Supp.2d 90 (D.D.C.2012)

Prevor II: Fast forward to 2014 and this time, the District Court for the District of Columbia again vacated FDA’s decision to designate Prevor’s DSW as a drug-device combination product with a “drug” primary mode of action. Ultimately FDA reached the same conclusion, yet found only one primary purpose: “to help prevent and minimize accidental chemical burn injuries.” The Court clarified that “as the record now stands, the Court cannot affirm FDA’s classification decision because it was based on an erroneous and unreasonable interpretation of the law.” . The Court rejected Prevor’s argument to classify the product as a medical device and or a combination product with a medical device as the primary mode. Yet, the District Court found that FDA action arbitrary and capricious.

Court Leaves Door Open:   FDA must consider the issue yet again. In essence, the  Court left the door open for FDA to reconsider the issues again; that is, the court stated that the FDA “could find that DSW should be classified as a drug-device combination product with a drug mode of action if it also adopts a plausible construction of the relevant statutory language.”  Chemical action and intent remain critical as the court set forth that classification is dependent on whether its chemical action will prevent and minimize chemical burns. Therefore, the court “left open” and remanded the designation decision to the FDA.

Next Steps: There is no definite conclusion nor is there finality. FDA will need to reconsider the issue and provide a basis in accordance with what the District Court stated about a “plausible construction of the statutory language”. No doubt the legal saga will continue.

Power Morcellators, Informed Consent, Laparoscopic Surgery, and Protocols …

 FDA ACTION

Power Morcellator

Laparoscopic Uterine Power Morcellation: Immediately in Effect Guidance Document: Product Labeling for Laparoscopic Power Morcellators; Guidance for Industry and Food and Drug Administration Staff http://www.gpo.gov/fdsys/pkg/FR-2014-11-25/html/2014-27857.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery

Laparoscopic Uterine Power Morcellation in Hysterectomy and Myomectomy: FDA Safety Communication http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm424443.htm

 Paying the Price of Not Being Fully Informed… Update 

Recently, the topic of laparoscopic hysterectomy or myomectomy for the treatment of fibroids and a procedure known as morcellation has become very controversial. What may seem like an everyday simple surgical procedure has become for some women the unwanted end result of invasive cancer.

The issues are quite complex. The purpose of this blog is to simply point out a few concepts to consider in the decision making process of whether a woman should undergo a full traditional surgical procedure or a  laparoscopic procedure. What may seem like a simple choice could potentially become a nightmare with a life changing outcome.

Today, more than ever, noninvasive surgery has become the “protocol” for many procedures. Yet, should it? The simple answer is that it depends on many factors. The single most important factor should be the patient and obtaining a valid informed consent. A valid informed consent should be videotaped. The patient must receive a “Plain English” explanation of the risks and benefits of such procedures.

It might sound “high tech” to use such a device approved by the United States Food and Drug Administration (FDA)  and the costs in terms of insurance might be beneficial to the to the insurer and insured. According to FDA: “Laparoscopic power morcellators are medical devices used during different types of laparoscopic (minimally invasive) surgeries. These can include certain procedures to treat uterine fibroids, such as removing the uterus (hysterectomy) or removing the uterine fibroids (myomectomy). Morcellation refers to the division of tissue into smaller pieces or fragments and is often used during laparoscopic surgeries to facilitate the removal of tissue through small incision sites.”  MedWatch

Yet, the question remains at what cost?

An excellent example is the removal of fibroids and morcellation without the benefit of a biopsy prior to the morcellation. What this means is if the fibroids are cancerous, the “morcellation procedure” spreads the cancer throughout the patient’s body. How? Power morcellators use extended, tube-shaped blades to cut uterine tissue into little pieces. This permits the surgeon who performs a laparoscopic or minimally invasive hysterectomy, to remove the tissue through a small incision.

Does it all come down to dollars and lack of informed conformed? Apparently so, as the practice continues and is sanctioned in protocols. According to physician Amy Reed: Morcellation is done in at least 11% of the nearly 500,000 hysterectomies are performed each year. See: http://www.usatoday.com/story/news/nation/2014/02/18/hysterectomy-laparoscopic-morcellation-amy-reed/5347093/

Benefit: Easier removal of the uterus and speedier recovery time rather than traditional abdominal surgery which could result in a large scar.

Major Risk: Undiagnosed cancer may be present and the morcellation process spreads the cancer.

FDA Warning, Guidance and Alerts, FDA Medical Device Advisory Committee Recommendations and Lawsuits 

Laparoscopic Uterine Power Morcellation: Immediately in Effect Guidance Document: Product Labeling for Laparoscopic Power Morcellators; Guidance for Industry and Food and Drug Administration Staff http://www.gpo.gov/fdsys/pkg/FR-2014-11-25/html/2014-27857.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery

Laparoscopic Uterine Power Morcellation in Hysterectomy and Myomectomy: FDA Safety Communication http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm424443.htm

FDA had  issued an alert in April 2014 to discourage the use of power morcellation. Specifically, FDA set forth: “laparoscopic power morcellation is performed in women with unsuspected uterine sarcoma, there is a risk that the procedure will spread the cancerous tissue within the abdomen and pelvis, significantly worsening the patient’s likelihood of long-term survival. For this reason, and because there is no reliable method for predicting whether a woman with fibroids may have a uterine sarcoma, the FDA discourages the use of laparoscopic power morcellation during hysterectomy or myomectomy for uterine fibroids.”

The Obstetrics and Gynecology Devices Panel of the Medical Devices Advisory Committee was convened by FDA on July 10 and 11, 2014. The committee discussed the “safety of laparoscopic power morcellator devices as it pertains to their potential to disseminate and upstage a confined, but undetected (occult) uterine malignancy during laparoscopic hysterectomy or myomectomy.” According to FDA the purpose of the committee meetings was to  “seek expert scientific and clinical opinion on the risks and benefits of these types of devices when used for these procedures, based on available scientific data.” The committee will make recommendations regarding the appropriate use, premarket testing, labeling, and other risk mitigations (including the use of containment bags) for these devices.

http://www.fda.gov/newsEvents/Newsroom/PressAnnouncements/ucm393689.htm  Quantitative Assessment of the Prevalence of Unsuspected Uterine Sarcoma in Women Undergoing Treatment of Uterine Fibroids Summary and Key Findings April 17, 2014 http://www.fda.gov/downloads/MedicalDevices/Safety/AlertsandNotices/UCM393589.pdf

See also: “New Cancer Risk Seen From Surgical Tool” in the Wall St. J. (July 23, 2014).

Lawsuits: Yes, lawsuits have been instituted. Yet, are lawsuits the solution? Here are suggestions to prevent what has occurred to date.

Recommendations

  • Medical Device companies who manufacture the device(s) used in these types of procedures should redesign the product and until that is done conduct a field correction recall of the medical device(s) in question. Ethicon Inc., a unit of Johnson & Johnson,  suspended the sales of several of its power morcellators and in July 2014 issued a market withdrawal.
  • Hospitals should consider a revised protocol and some hospitals have already temporarily banned morcellation until the risk can be more fully evaluated.
  • Physicians should offer “informed” options to the patient.
  • Informed consent should be just that- a plain language explanation of the benefits and risks of consenting to this type of procedure.

Stay tuned for more on this critical health medical-legal issue as the FDA Advisory Committee will issue recommendations pertaining to  appropriate use, premarket testing, labeling, and other risk mitigations such as containment bags) for these devices.

This blog was written by Roseann B. Termini, Esq. with insight and review by Desencia E. Thomas, M.D.

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.