Delays in DSCSA Deadlines, Again

time-train-station-clock-deadlineIt’s true the last week of November 2015 came and went without any real repercussions owing to the FDA’s lack of compliance when it came to a deadline for publishing their new guidance documents under the Drug Supply Chain Security Act. This isn’t the first time that the FDA has not met its purported deadline for publishing, in fact the same thing happened last year around the same time. But what is it exactly that is causing this delay in guidance documents?

While the exact cause may remain largely unknown, this does present an opportune time to examine the logistics and funding involved in mounting this particular effort.

It’s important to note that although these guidance documents are mandated under legislation signed by the president and recognized by congress, the DSCSA is currently an “unfunded” mandate unto itself.

Without any context, that may make it seem improbable that any guidances would ever get published.  However, the FDA submits an estimated budget proposal annually which outlines and supports the overall funding of Congressional Appropriations Committees and include time allocated to implementing the DSCSA.

Knowing that the funding for this mandate is not its own line item within the budget makes it seem like this could easily lead to a lack of prioritization when it comes to publishing these documents on time.

While this somewhat informal way of allocating resources to this cause may work well enough for now, it’s likely that the costs associated with implementing the “Enhanced Drug Distribution Security” (EDDS) (slated for late 2023) will require additional funds and likely a more detailed understanding of where it’s coming from and specific numbers.

In the meantime, however, we will have to wait and see how the FDA will approach this deviation from the proposed publishing date for these guidances related to the DSCSA.

Idaho Joins Multimillion Dollar Lawsuit Against Qualitest Pharmaceuticals

Idaho recently joined 47 other states and the federal government in a settlement against Qualitest Pharmaceuticals due to their mislabeled Qualitest-branded multivitamin, according to Attorney General Lawrence Wasden.

Qualitest, a manufacturer of generic pharmaceutical products owned by Endo Pharmaceuticals, profited from misinformation. Through labeling and promotion, they indicated that their vitamins contained the level of fluoride recommended by the U.S. Food and Drug Administration (FDA) and the American Dental Association (ADA). In reality, it had half that amount.

Dr. Stephan Porter, a dentist in Florida, originally blew the whistle, sharing the news about Qualitest tablets to light after learning about the actual levels of fluoride used, according to New York Attorney General Eric Schneiderman.

Qualitest will pay $87,467 to Idaho, resolving the allegation of unlawful labeling practices. Overall, Qualitest is set to pay $39,000,000 to the 48 states and federal governments, plus taxes. The National Association of Medicaid Fraud Control Units worked alongside the federal government to investigate and plan settlement negotiations.

Additionally, more than 100 women filed a suit against the aforementioned pharmaceutical company because they allegedly mispackaging birth control pill, resulting in unwanted pregnancies.

On February 1st, a new initiative honoring the Qualitest name was announced by parent company Endo. The Qualitest Scholarship Program was designed to be awarded to students pursuing higher education in the Huntsville, Alabama region.

New FDA Guidance reveals new dates for Mandated DSCSA Compliance

In November of 2013, President Obama signed the Drug Supply Chain Security Act (or DSCSA) into law, which incited a ten year roll out plan of new compliance standards for those in the pharmaceutical industry.

The purpose of the act is to strengthen security measures in place regarding the distribution and supply chain of pharmaceutical drug products. The FDA plays a large role in implementing these new measures such as; the planned national track and trace system and new standards in licensing for prescription drug wholesale distributors and 3PLs.

Although different aspects of the DSCSA will be implemented over a ten year period, a new series of penalties are in effect as of November 1, 2015 for failure to comply. Although much of this new information can be somewhat confusing (ie identifying compulsory law vs FDA guidance or suggestions), keep in mind that rules set forth from the DSCSA and the FDA require compliance by law, whereas FDA guidances are suggestions and reflect the current thinking of the Food and Drug Administration.

On October 28, 2015 theFDA issued a guidance to inform industry that they do not plan to take action against dispensers who (prior to March 1, 201)  accept ownership of pharmaceutical products without receiving the product tracing information, as required by section 582(d)(1)(A)(i) of the FD&C Act.

Prior to March 1, 2016, the FDA also does not plan to take any actions against dispensers who do not capture and maintain the product tracing information, as required by section 582(d)(1)(A)(iii) of the FD&C Act.

However, an important thing to note about this particular guidance is the fact that this policy does not extend to transactions wherein dispensers must provide the subsequent owner with product tracing information.

Also, other product tracing requirements about authorized trading partners and verification related to suspect and illegitimate product (including quarantine, investigation, notification and recordkeeping) still apply and are in effect for dispensers.

 

The NABP and You

No matter where one is in the supply chain when it comes to managing or handling prescription drugs, compliance is key. While there are some standards that one needs to understand on a national level, there are also many laws and regulations that act on a state level. For those working in Florida, an intimate familiarity with and understanding of organizations like the Florida Department of Environmental Protection and the Florida Department of Business and Professional Regulation are key, but there is still so much information surrounding compliance. Another important resource for better understanding the industry is the National Association of Boards of Pharmacy.

This professional organization serves as an unbiased group that supports the vision of the state boards of pharmacy in attempting to protect public health.

Origins

The NABP was founded in 1904, and has maintained that initial goal throughout the duration of it’s more than century-long existence.

While the infrastructure has undergone some changes since its inception, the NABP has not wavered from this initial vision, and continues to oversee measures that support the interest of public health.

 

NABP Today

The NABP maintains a variety of means to ensure this mission. It coordinates a number of programs that include accreditation programs for distributors of wholesale products and online pharmacies, pharmacist competency evaluation programs and pharmacist license transfers. For those in the field, many will be familiar with the following accreditation programs; Verified Internet Pharmacy Practice Sites CM (VIPPS®), Vet-VIPPS®, Verified-Accredited Wholesale Distributors® (VAWD®), and durable medical equipment, prosthetics, orthotics, and supplies (DMEPOS) accreditation programs.

Although the organization was founded in the US, it currently oversees eight districts that include all fifty states, the District of Columbia, Guam, New Zealand, the Virgin Islands, Australia, Puerto Rico and 8 provinces in Canada. The Executive Committee is comprised of officers elected during the NABP’s Annual Meeting, and this Committee governs the districts. This group consists of three officers, eight members, and a chairperson. Each elected official dedicates his or her time and expertise to overseeing the implementation of policy, Association programs and activities intended to further the organization’s mission statement.

While the National Association of Boards of Pharmacy may seem like a secondary organization to some (depending on your role in the field), it’s important that those involved in the pharmaceutical industry at all levels of the supply chain understand the initiatives and policies set forth by their local district.

 

Physician Self-Referral Today

A Brief History of Physician Self-Referral

Sharon Roberts Physician Self-ReferralAccording to the most recently available data, federal reports reveal that the number of doctors referring patients to businesses in which they have a vested monetary interest is on the rise.

The practice of “physician self-referrals” has undergone a number of regulations since 1989. Combined, these self-referral laws prohibit government-backed payments from Medicare and Medicaid when a physician refers any of ten “designated health services” (DHS) to an entity where the physician or his immediate family member has a financial relationship unless an exemption applies. Again, these laws pertain specifically to physicians. 

Stark 1

In 1989 congress included a provision in the Omnibus Budget Reconciliation Act (OBRA 1989). This provision  prohibited self-referrals for clinical laboratory services under the Medicare program, beginning January 1 of 1992. This provision was more popularly known as “Stark I”.

Stark II

Again in 1993, Congress implemented The Omnibus Budget Reconciliation Act (OBRA 1993) and expanded this restriction to include a broader range of health services and applied it to both Medicare and Medicaid.  This provision, often referred to as “Stark II”, specified more clearly the exceptions to the initial law.

Exceptions to Stark I and Stark II

Both provisions were put into effect to prohibit the practice of physician self-referral. However, employees and contractors of physicians are exempt from this law when providing in-office ancillary services. Furthermore, physician employees or contractors are exempt from these provisions under the condition that their services are:

• supervised either by the referring physician or by a physician also belonging to the same group practice

• performed in a location where the referring or group physician provides non-DHS services; or in a centralized site used exclusively by the group for providing DHS

• billed by the physician overseeing the services, by a group practice to which the physician belongs, or by an entity that is owned entirely by such a physician or group practice

Additionally, certain financial relationships between an audiologist or speech-language pathologist and physician are protected as long as requirements outlined in the “safe harbor” regulations are adhered to.

The GAO and Physician Self-Referral

The U.S. Government Accountability Office (GAO) is an independent, nonpartisan agency that works for Congress, and is often referred to as the “congressional watchdog”. From 2010 to 2014, the GAO focused specifically on gathering data regarding this practice of physician self-referral. The resulting 4 reports examined services that included advanced imaging, radiation therapy, anatomic pathology and physical therapy. These GAO reports are the most recent audit of physicians who refer their patients to service facilities wherein these physicians (or an immediate family member) have a financial interest.

In February of 2015, the Journal of the American Medical Association published and article by Dr. Eli Y. Adashi, MD and MS and Robert P. Kocher, MD. This article shares the findings from the GAO’s reports, examines the topic of physician self-referral, considers the regulatory system in which it continues, and presents potential solutions to this challenge.

This recent attention on the topic suggests the importance for physicians and secondary businesses to familiarize themselves fully with these laws and provisions, and conduct themselves in full adherence to said laws.

Third Party Auditors in the Pharma Industy

Did you know that most State Laws require that entities that buy and sell prescription drugs conduct due diligence inspections of their proposed vendors prior to doing business?  Did you also know that State laws also allow entities to hire Third Party auditors to conduct these due diligent audits on their behalf?

Consider hiring a qualified Third Party Auditing Service like Roberts Consulting Services to travel, observe, interview, collect data and provide a audit report that will meet both your FDA and State requirements for due diligence when buying and selling prescription drugs.  Beware when hiring an auditor as most companies are FDA based ONLY and have little to no knowledge regarding the unique State laws that regulate Prescription Drug Wholesale Distributors and Third Party Logistic Providers.