Final Rule Issued: Intended Use ….. Far From the Final Word.

What does FDA say? Recently FDA published a final rule about the following-  “Intended Use”-Products Made from Tobacco. Is my product a Drug, Device and/or Both? Here is the rule summary and link.  Check back  soon for an update.  bit.ly/2lxvPiO

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 201, 801, and 1100 [Docket No. FDA–2015–N–2002]
RIN 0910–AH19

Clarification of When Products Made or Derived From Tobacco Are Regulated as Drugs, Devices, or Combination Products; Amendments to Regulations Regarding ‘‘Intended Uses’’

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

SUMMARY: The Food and Drug Administration (FDA) is issuing this final rule to describe the circumstances in which a product made or derived from tobacco that is intended for human consumption will be subject to regulation as a drug, device, or a combination product under the Federal Food, Drug, and Cosmetic Act (the FD&C Act). This action is intended to provide direction to regulated industry and to help avoid consumer confusion.

 

Check back  soon for an update.  bit.ly/2lxvPiO

Sandoz’s Biosimilar Zarxio Marketplace Entry Delayed

Sandoz’s  Biosimilar Zarxio Marketplace Entry Delayed

Patients will need to wait for Zarxio,the biosimilar of Amgen’s cancer treatment Neupogen. Zarxio is the first biosimilar that was approved (March 6, 2015) in the United States under the abbreviated approval pathway of the Biologics Price Competition and Innovation Act (BPCIA).  The direct link to the federal court of appeals opinion is below.

Synopsis—In an Appeal from the United States District Court for the Northern District of California in No. 3:14-cv-04741-RS, the Federal Circuit Court of Appeals on July 21, 2015 interpreted the advance notice provision in a manner that effectively delays marketplace entry. This means that Sandoz’s release of Zarxio, its biosimilar of Amgen’s cancer treatment Neupogen, will not occur until Sept. 2. How the Court of Appeals interpreted the advance-notice provision is a significant victory for brand-name biologics.

District Court Interpretation—The district court had determined that the statute only required it to provide notice 180 days before it commercially marketed the biosimilar and that Sandoz had given Amgen such notice on July 14, 2014, when it filed its biosimilar application with the FDA.

Federal Court of Appeals Interpretation—Yet, the federal court of appeals, determined that notice of a biosimilar must be given to the biologic brand reference product sponsor (RPS) not later than 180 days after the Food and Drug Administration approves/licenses the biosimilar. The court of appeals stated: “We agree with Amgen that, under paragraph (l)(8)(A), a subsection (k) applicant may only give effective notice of commercial marketing after the FDA has licensed its product. That is,the Appeals Court determined that based on the language in the BPCIA, notice be provided after the biosimilar product is licensed by the FDA.

The direct link to the official Federal Circuit opinion is: Amgen, Inc. v. Sandoz, Inc.

Calorie Disclosure FDA Final Rule Effective Date Extended to 2016

Quick Summary-Final Rules for Vending Machines and Restaurant Menu Labelling 

New Effective Date December 1, 2016 for both Rules 

http://www.fda.gov/Food/NewsEvents/ConstituentUpdates/ucm453529.htm

Key Links http://www.fda.gov/Food/NewsEvents/ConstituentUpdates/ucm423987.htm

http://www.fda.gov/Food/IngredientsPackagingLabeling/LabelingNutrition/ucm248732.htm

Background: In December 2014, FDA released two final rules regarding caloric disclosure for final publication in the Federal Register. The rules were proposed in April 2011 under section 4205 of the Affordable Care Act and are both now effective December 1, 2016.

Reason for Vending Machine Rule-Food Labeling; Calorie Labeling of Articles of Food in Vending MachinesThe purpose  of the final rule is to assist consumers by requiring the availability of point of purchase nutrition caloric information prior to purchasing the food item. 

Vending Machines-Who Must Comply? 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.

Reason for Food Labeling Rule: Nutrition Labeling of Standard Menu Items in Restaurants and Similar Retail Food Establishments. The purpose of the final rule also published December 1, 2014 is to implement the menu labeling provisions of the Affordable Care Act to assist consumers by requiring the availability of point of purchase nutrition caloric information for informed decision making prior to purchasing the food item.  See FDA Summary Below.

Menu Labelling-Who Must Comply? 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.

FDA Summary: A restaurant or similar retail food establishment is generally defined as a retail establishment that offers for sale restaurant-type food, which is generally defined as food that is usually eaten on the premises of the establishment, while walking away, or soon after arriving at another location. Examples of restaurants and similar retail food establishments include sit-down and fast-food restaurants, bakeries, coffee shops and grocery and convenience stores. The menu labeling final rule also requires calorie labeling for certain alcoholic beverages and certain foods sold at entertainment venues such as movie theaters and amusement parks. The FDA also clarifies in the menu labeling final rule that certain foods purchased in grocery stores or other retail food establishments that are typically intended for more than one person to eat and require additional preparation before consuming, such as pounds of deli meats and cheeses and large-size deli salads, are not covered.To help consumers understand the significance of the calorie information in the context of a total daily diet, the FDA is requiring a succinct statement that says, “2,000 calories a day is used for general nutrition advice, but calorie needs vary” to be included on menus and menu boards. The menu labeling final rule also requires covered establishments to provide, upon consumer request, written nutrition information about total calories, total fat, calories from fat, saturated fat, trans fat, cholesterol, sodium, total carbohydrates, fiber, sugars and protein.

The vending machine final rule requires operators who own or operate 20 or more vending machines to disclose calorie information for food sold from vending machines, subject to certain exceptions. Vending machine operators that are covered, including those that voluntarily register with FDA to comply with the vending machine labeling requirements, will have two years from the date of publication of the vending machine labeling final rule to comply with the requirements.

Conclusion and Recommendation The caloric disclosure is a step in the correct direction since the obesity rate and diet related diseases has again risen in the United States. Is caloric disclosure sufficient in terms of right to know? What other disclosures should FDA institute?

Lethal Injection “Cocktail” Upheld

The United States Supreme Court (June 29, 2015) held in Glossip v. Gross http://1.usa.gov/1HsooTz that states can continue to utilize the controversial lethal injection “cocktail”. The U.S. Supreme Court articulated that  the plaintiffs haven’t shown the drug poses a serious risk of inflicting unconstitutional pain and suffering under the Eighth Amendment. In contrast to the botched execution of Clayton Lockett, the protocol discussed in Glossip uses a much greater dosage of midazolam.

Read the official opinion here: http://1.usa.gov/1HsooTz

Future: How will this decision affect pharma companies both nationally and internationally?

FDA Landmark Ban: Partially Hydrogenated Oils and Trans Fat

Partially Hydrogenated Oil and Trans Fatty Acids-GRAS Removal

Landmark Ban from GRAS List:  In June 2015, FDA issued a landmark determination that partially hydrogenated oils (PHOs) are not “generally recognized as safe” (GRAS) for use in food. http://www.regulations.gov/#!docketDetail;D=FDA-2013-N-1317 The “declaratory order” (which has the “force and effect” of a rule) was issued pursuant to 5 U.S.C. 554(e) (section 5(d) of the Administrative Procedure Act (APA)). PHOs are the principal dietary source of artificial trans fat in processed foods. This decision means that the use of these oils in the food supply will be phased out over a number of years and removed from the United States food supply. In so doing, FDA estimates that annually approximately 7,000 deaths from heart would be prevented. FDA received 6000 comments and 4500 letters in response to the November 2013 notice about the FDA tentative determination regarding the GRAS elimination. The Federal Register notice concerning hydrogenated fat was published November 8, 2013 (78 FR 67169) and the comment period was extended until March 8, 2014. Upon review of the comments FDA found that there is no longer a consensus among qualified experts that partially hydrogenated oils (PHOs), which are the primary dietary source of industrially-produced trans fatty acids (IP-TFA) are generally recognized as safe (GRAS) for any use in human food.

Background: Years ago, studies revealed that the consumption of trans fatty acids contribute to increased blood LDL cholesterol, known as the “bad” cholesterol, thereby raising the risk of coronary heart disease. Trans fatty acids or trans fat are made through the process of hydrogenation that solidifies liquid oils. Types of foods that may contain trans fatty acids include vegetable shortenings, some margarines, some cookies and some snack foods. A citizen’s petition (docket number 94-P0036/CP1), filed in 1994 by the Center for Science in the Public Interest (CSPI), addressed the issue of dietary trans fats and the link to coronary heart disease. A proposed rule was published in the Federal Register (64 FR 62746 November 17, 1999). FDA extended the comment period to April 17, 2000 (65 FR 7806); however, the proposal generated enormous response and the comment period was reopened until January 19, 2001 (65 FR 75887 December 5, 2000). The final rule, (68 FR 41434 July 11, 2003) effective January 1, 2006, required the declaration of trans fatty acids or trans fats on nutrition labels of conventional foods and dietary supplements. However, since implementation of the trans fat regulation, FDA found that although many processed foods have been reformulated to reduce the amount of trans fat, a significant number of products still contain PHOs.

What the Order Means: The FDA Order specific to the PHO ban means that food manufacturers would no longer be permitted to sell PHOs, either directly or as ingredients in another food product, without prior FDA approval for use as a food additive. This means compelling scientific demonstrating that the proposed use is reasonably certain not to present a risk of harm to consumers.  A good review of the Final Order is available at:

http://www.fda.gov/Food/IngredientsPackagingLabeling/FoodAdditivesIngredients/ucm449162.htm

Compliance Date:  No later than June 18, 2018.

Looking Ahead: There is a three-year phase-out period for reformulation and product relabeling. Did FDA utilize the correct approach? Apparently, it is a long time in coming and FDA is mandated under the Food, Drug, and Cosmetic Act to protect the public. Valid scientific evidence exists today that the GRAS removal is long overdue. The issue is whether industry will comply without legal challenges. Yet, it is likely that litigation will result from the FDA Order and Determination to Ban PHOs from the GRAS list.

Pay for Delay Settlement- Teva Pharmaceutical Industries, Ltd.

Pay-for-Delay Settlement-$1.2 Billion Announced May 28,2015

FTC v. Cephalon, Inc., E.D. Pa., No. 2:08-cv-2141

Teva Pharmaceutical Industries Ltd. (Teva) agreed to pay $1.2 billion in a Settlement with the Federal Trade Commission.   Teva acquired Cephalon, Inc. in 2012. The settlement resolves claims that Cephalon Inc., hindered generic drug competition.

FDA TOP NOTABLES- Mobile Med. Apps., Reprocessed Medical Devices, Guilty Plea, Consent Decree, Biosimilar Approval, 23andMe Direct to Consumer Test Kits

TOP FDA NOTABLES 1st QUARTER 2015

REPROCESSED DEVICES 

Guidance Issued-Infection Prevention and Safety http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm437804.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery

McNeil-PPC Inc. GUILTY PLEA

McNeil-PPC Inc. a subsidiary of Johnson & Johnson-Guilty Plea March 10, 2015 $25 million manufacturing adulterated Infants’ and Children’s Tylenol and Children’s Motrin. http://1.usa.gov/1AeQ2JS 

MOBILE MEDICAL APPS-GUIDANCE

The Mobile Medical Applications Guidance for Industry and Food and Drug Administration Staff issued February 9, 2015 supersedes the September 25, 2013 issued guidance. It was updated for consistency with the guidance document Medical Devices Data Systems, Medical Image Storage Devices, and Medical Image Communications Devices issued on February 9, 2015. See: 76 Fed. Reg. 140 (July 21, 2011). http://1.usa.gov/1DrPGXm

Examples of Mobile Apps-FDA Enforcement Discretion http://1.usa.gov/Px0cpU

DIRECT-to-CONSUMER GENETIC TESTING KIT APPROVED

23andMe, Inc. submitted a revised 510(k) application for its direct-to-consumer genetic testing service focusing on a single rare inherited condition. In 2015 (Feb.) FDA authorized marketing of 23andMe’s Bloom Syndrome carrier test, a direct-to-consumer (DTC) genetic test to determine whether a healthy person has a variant in a gene that could lead to their offspring inheriting the serious disorder. Additionally, FDA classified carrier screening tests as class II. Further, the FDA exempts these devices from premarket review. http://1.usa.gov/18SbIVz Interestingly, 23andMe received a two year $1.3 million NIH grant in 2014 (July) to support further development of its Web-based database and research engine to stimulate genetic discoveries. According to 23andME, the funding will enable it to use its stored genetic data on thousands of diseases and traits for over 400,000 people to pursue research endeavors and detect novel and rare genetic associations with health conditions.

BIOSIMILAR APPROVAL- NOVARTIS

The first biosimilar drug for cancer named Zarxio by Novartis AG received approval in early 2015. The ramifications of the approval of Novartis AG’s form of Amgen Inc.’s cancer drug, Neupogen, are huge. That is, this biosimilar approval means lower costs and patient access to less expensive treatments. Zarxio received FDA approval for all five conditions to treat associated to white blood cell counts. Novartis agreed to delay selling the biosimilar in the United States until April 10, 2015 due to a lawsuit with Amgen. An unresolved issue it that of naming. Generic drugs are named after the active ingredient for uniformity. The active ingredient in Neupogen is filgrastim and FDA determined that Zarxio’s name is filgrastim-sndz. http://1.usa.gov/1frRQcv

CONSENT DECREE- SPECIALITY COMPOUNDING LLC

A consent decree entered against Specialty Compounding LLC, of Cedar Park, Texas, and the company’s co-owners, Raymond L. Solano, III and William L. Swail. According to the complaint filed with the consent decree, Specialty Compounding manufactured purportedly sterile injectable drug products that tested positive for bacterial contamination. Veterinarians should be aware that Specialty Compounding also manufactured products intended for use in animals, and that these products are also affected by the consent decree. Specialty Compounding ceased sterile drug manufacturing operations in August 2013, and recalled all lots of its unexpired sterile drug products distributed since February 1, 2013.

http://www.fda.gov/AnimalVeterinary/NewsEvents/CVMUpdates/ucm437742.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery

http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm437682.htm

STAY TUNED! Will post updated news next quarter 2015!