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.
TOP FDA NOTABLES 1st QUARTER 2015
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. 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
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
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.
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/NewsEvents/Newsroom/PressAnnouncements/ucm437682.htm
STAY TUNED! Will post updated news next quarter 2015!
Does a shipper such as FedX or United Parcel Service, INC. (UPS) have a legal duty to refuse to ship drug products to United States customers who obtain controlled substances and prescription drugs without a prescription from “Internet Pharmacies”? UPS agreed in 2013 to a “Nonprosecution Agreement” with the United States Department of Justice in which the company agreed to forfeit $40 million in payments it received from illicit online pharmacies. UPS agreed to institute a compliance program to assure that illegal online pharmacies will not be able to use UPS for shipment. For example, an online pharmacy compliance officer position is responsible to implement, monitor and provide regular reports to UPS’s chief executive officer. According to FDA and the Department of Justice, UPS was on notice since 2004 that Internet pharmacies were illegally shipping prescription through common carriers such as UPS. Yet, despite a compliance program instituted in 2004, it was deemed ineffective. See: UPS Agrees To Forfeit $40 Million In Payments From Illicit Online Pharmacies For Shipping Service
More recently, FedEx Corporation was charged See: United States v. FedEx Corp., N.D. Cal., No. 14-cr-00380, indictment 7/17/14) /See: FDA FedEx Indictment. The grand jury issued a 15 count indictment . If there is a conviction FedEx could face fines, penalties, forfeiture. Most likely, there would be mandatory compliance parameters as well. See also: FDA News Release.
The United States Supreme Court issued an Order on July 3, 2014 shortly after the Hobby Lobby decision concerning the pending case of Wheaton College v. Burwell.
The Order in part provides: “If the applicant informs the Secretary of Health and Human Services in writing that it is a non- profit organization that holds itself out as religious and has religious objections to providing coverage for contraceptive services, the respondents are enjoined from enforcing against the applicant the challenged provisions of the Patient Protection and Affordable Care Act and related regulations pending final disposition of appellate review. To meet the condition for injunction pending appeal, the applicant need not use the form prescribed by the Government, EBSA Form 700, and need not send copies to health insurance issuers or third-party administrators.
The Circuit Courts have divided on whether to enjoin the requirement that religious nonprofit organizations use EBSA Form 700. Such division is a traditional ground for certiorari. See S. Ct. Rule 10(a).
Nothing in this interim order affects the ability of the applicant’s employees and students to obtain, without cost, the full range of FDA approved contraceptives. The Gov- ernment contends that the applicant’s health insurance issuer and third-party administrator are required by federal law to provide full contraceptive coverage regard- less whether the applicant completes EBSA Form 700.
The applicant contends, by contrast, that the obligations of its health insurance issuer and third-party administrator are dependent on their receipt of notice that the applicant objects to the contraceptive coverage requirement. But the applicant has already notified the Government— without using EBSA Form 700—that it meets the re- quirements for exemption from the contraceptive coverage requirement on religious grounds. Nothing in this order precludes the Government from relying on this notice, to the extent it considers it necessary, to facilitate the provi- sion of full contraceptive coverage under the Act.In light of the foregoing, this order should not be con strued as an expression of the Court’s views on the merits.
The full Order including the dissent by Justice Sotomajor joined by Justices Kagan and Ginsburg is directly linked here: Wheaton College v. Burwell.
The Supreme Court decided the case known as “Hobby Lobby”. The direct link to the official opinion follows the Court holding. Page #’s refer to pages in opinion.
Held: As applied to closely held corporations, the HHS regulations imposing the contraceptive mandate violate the [Religious Freedom Restoration Act of 1993] RFRA. Pp. 16–49.
(a) RFRA applies to regulations that govern the activities of closely held for-profit corporations like Conestoga, Hobby Lobby, and Mardel. Pp. 16–31.
(1) HHS argues that the companies cannot sue because they are for-profit corporations, and that the owners cannot sue because the regulations apply only to the companies, but that would leave merchants with a difficult choice: give up the right to seek judicial protection of their religious liberty or forgo the benefits of operating as corporations. RFRA’s text shows that Congress designed the statute to provide very broad protection for religious liberty and did not intend to put merchants to such a choice. It employed the familiar legal fic- tion of including corporations within RFRA’s definition of “persons,” but the purpose of extending rights to corporations is to protect the rights of people associated with the corporation, including shareholders, officers, and employees. Protecting the free-exercise rights of closely held corporations thus protects the religious liberty of the humans who own and control them. Pp. 16–19.
http://www.supremecourt.gov/opinions/13pdf/13-354_olp1.pdf
Besides air, water and soil did you know that arsenic is found in some food? Arsenic can be either inorganic or organic and the type of arsenic matters. Inorganic forms of arsenic are the harmful types and organic forms of arsenic are basically harmless. Both forms of arsenic have been found in soil. Until 1970 arsenic-based pesticides were regularly used in United States agricultural production. Consequently, trace levels of organic and inorganic forms of arsenic can be detected in some agri-business settings. Consequently, there could be arsenic in certain food and beverage products such as apple juice and rice. Does FDA monitor level of arsenic in food? Although FDA has been monitoring the levels of arsenic in foods for several years testing has increased.
Why Test? The short answer is that it is a step in the right direction to test and understand possible arsenic-related risks associated with the consumption of certain foods and remediate if necessary.
“A” is for Apple Juice and Also for Arsenic in Apple Juice
Several years ago, consumer advocates rallied for regulation of arsenic in apple juice. After years of debate, dialog and testing FDA did issue a guidance albeit in draft format in 2013 about acceptable levels in apple juice. Here is the latest.
According to FDA, the agency does not have clear data that demonstrates organic juice is better than non-organic apple juice in terms of arsenic levels. This is due to the soil where apple juice is grown.
FDA published a draft guidance in the Federal Register July 15, 2013 (78 FR 42086). The guidance identifies an action level for inorganic arsenic in apple juice that FDA deems both safe and viable under good manufacturing practices. It also describes the FDA’s intended sampling and enforcement approach. The draft guidance proposes an action level of 10 parts per billion (ppb) for inorganic arsenic in apple juice. This is the same level set by the U.S. Environmental Protection Agency for arsenic in drinking water. The U.S. Food and Drug Administration (FDA) has extended by 60 days the period for submission of comments, scientific data and other information in connection with its draft guidance for industry titled “Arsenic in Apple Juice: Action Level.” The new deadline is November 12, 2013.
FDA released on September 6, 2013 the analytical results of nearly 1,100 new samples of rice and rice products. Approximately one year ago, FDA initially tested 200 samples of rice and rice products. In addition to the analytical results above, the following provide useful information about Arsenic in Rice and Rice Products.
Immediate Short Term Findings
While levels varied significantly depending on the product tested, agency scientists determined that the amount of detectable arsenic is too low in the rice and rice product samples to cause any immediate or short-term adverse health effects.
Long Term Plan-What are FDA’s future plans concerning rice and rice products that contain arsenic? According to FDA, the next steps are to assess the potential health risk from long-term exposure to the arsenic in rice and foods made with this grain.
FDA needs to understand first and then issue regulations to address possible arsenic-related risks associated with the consumption of these foods. FDA is on the right path with apple juice products. Yet, the question remains how long will these next steps take for other foods that might contain arsenic?
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. Major accomplishments include a final rule and four proposed rules.Here is a synopsis of the final and proposed rules.
Criteria Used to Order Administrative Detention of Food for Human or Animal Consumption which amended the criteria for administrative detention to prevent potentially unsafe food from reaching the marketplace. The final rule issued February 2013 adopts the interim final rule, “Criteria Used to Order Administrative Detention of Food for Human or Animal Consumption,” published in May 2011, without change.
On March 7, FDA released a revised guidance on administrative detention entitled “Guidance for Industry: What You Need to Know About Administrative Detention of Foods; Small Entity Compliance Guide.”
Proposed Rule on Preventive Controls for Human Food
Preventive Controls Major Provisions Summary: This proposed rule, issued January 2013, would implement the requirements of FSMA for covered facilities to establish and implement a food safety system that includes hazard analysis and risk-based preventive controls. Specifically, the proposed rule would establish requirements for:
Proposed Rule for Produce Safety
Produce Safety Major Provisions Summary: This proposed rule would establish science-based minimum standards for the safe growing, harvesting, packing, and holding of produce on farms. The following are the proposed new standards in the following major areas:
Foreign Supplier Verification Program
Foreign Supplier Verification Programs (FSVP) for Importers of Food for Humans and Animals Summary: On July 26, 2013, FDA issued proposed regulations that would greatly strengthen the oversight of foods imported for U.S. consumers. Under the Foreign Supplier Verification Program (FSVP) regulations, importers would be required to perform certain risk-based activities to verify that food imported into the United States has been produced in a manner that provides the same level of public health protection as that required of domestic food producers. The FSVP regulations would implement section 301 of the FDA Food Safety Modernization Act (FSMA).
FSVP Requirements: Under the proposed FSVP regulations, an importer would be required to develop, maintain, and follow an FSVP for each food it imports, which, in general, would need to include the following:
Third Party Accreditation of Auditors or “Certification Bodies”
Accreditation Rule Summary: On July 26, 2013, the FDA published for public comment its proposed rule to establish a program for accreditation of third-party auditors, also known as certification bodies, to conduct food safety audits and issue certifications of foreign facilities and the foods for humans and animals they produce. The proposed rule would implement Section 307 of the FDA Food Safety Modernization Act (FSMA). The proposed rule contains requirements relating to auditing and certification of foreign food facilities and food under the program and for notifying the FDA of conditions in an audited facility that could cause or contribute to a serious risk to the public health.
Model Accreditation Standards Although not part of the proposed rule, the FDA plans to issue draft model accreditation standards that would specify what qualifications a certification body must have to qualify for accreditation, such as the minimum requirements for education and experience for third-party auditors and their audit agents. FDA will issue the Model Accreditation Standards in draft and open a docket to accept comments. After considering the comments received, the FDA will finalize the standards.
The major issue with these proposals involves the timeframe for these proposed rules. Many will opine that FDA is again “dragging its feet”. After all, the Food Safety Modernization Act was signed into law in early January 2011. Now, over two years later FDA finally announced four proposed rules and only one final rule was solidified. Why did it take so long or did it? The answer is far from clear cut. Perhaps the lengthy timeframe as some would argue is because these are complicated issues and FDA needs to ensure that administrative law due process procedures are adhered to with proper notice and comment. The question remains though as to when the four proposed rules will be finalized. If FDA receives comments that would essentially change the proposed rule in a substantial manner, then FDA would have to return to the “drawing board” and announce a new proposed rule(s). Hopefully, that will not occur as the safety of the United States food supply remains at stake.
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