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Title VII of the Civil Rights Act of 1964 and state extensions of Title VII when added to the ADA, FMLA, ADEA, EPA, FLSA, USERRA, PDA, OSHA, OFCCP, Affirmative Action, Workers Compensation, Minimum Wage, with many others, create a

According to USFDA, a combination product is one composed of any combination of a drug and device; biological product and device; drug and biological product

firestorm of confusion for those who are unfamiliar with employment laws. What is confounding is that any one of these laws with the exception of Title VII can change abruptly with court decisions and also yearly with Congressiona

; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

Examples of combination products may in

, state, local, or legal decisions or actions. If an employer or an employee were to actually take a comprehensive look at the myriad of employment laws that protect the employee or that the employer is legally required to be awar

lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

of and adhere to, their heads would spin!

Employers and employees constantly ask me the question, “Does this law pertain to me? The answer is not always a pure yes or no. An employment law may apply to some employers or employe

here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe

s and may not with others depending upon how many employees an employer has or possibly whether the employer is a federal contractor or not or even s where the employer may be located.

A perfect example is Title VII of the Civil R

d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

Combination pro

ghts Act of 1964 which prohibits employment discrimination based upon race, religion, color, national origin, sex or handicap. Maryland takes this a few steps further to include sexual preference, familial status, and genetic code

ucts have become life saving products for the pharmaceutical companies who doesn’t have many innovative molecules in their product pipeline and have been inc

Baltimore Maryland takes it even one step further with protection for the category of transgender. Since Johns Hopkins Hospital is within the Baltimore city limits, it must adhere to all of the above stated protected categories.

easingly used in the product life cycle management. Even the companies having product patents are trying to extend their product life cycle through the combi

A neighboring employer in a city such as Towson adjacent to the Baltimore city limits would not have to have protection for transgender and a city such as McLean, Virginia less than 45 miles away would not have protection for gen

nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically

tic code, transgender, or familial status but would still maintain the Federal law that applies to everyone…well almost everyone.

Now, when you take into consideration that Title VII and any or all extensions thereof is applicable

and physically. They need to rightly judge the benefits of the combination products and they have to even look at the risks involved when combining the produ

to only for employers of who have 15 or more employees, the ADEA applies to employers who have 20 or more employees, and the EPA applies to employers with any number of employees, the confusion for employers and employees is readil

ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi

apparent.

Employment laws sometimes contradict long established personnel policies that have failed to realize changes through legislation or legal decisions that affect compensation, payment of earned vacation or other earned be

ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

Following aspects would a

efits. Those contradictions can be a ticking time bomb waiting for a lawsuit to occur or for sanctions to be applied. The Federal Department of Labor or EEOC, just like the IRS with taxes, is not amenable to employers claiming t

dd to the challenges in developing combination products:

Which markets to tap where the combination products can do fairly well?
Which combination prod

be ignorant of employment laws that pertain to them.

What can be done to prevent either a misapplication or violation of employment laws? First of all an employer contemplating opening a business should be cognizant of employmen

cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin

laws that pertain to that business prior to opening the door for their first day. Second, the employer should hire a professional EEO Officer well trained with expert knowledge and application of employment laws and who is an exp

tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen

erienced EEO Investigator in the workplace. Employers should not rely solely upon human resource generalist to make these decisions. While HR generalist may have some knowledge of employment laws, it has been my experience that

t?

As combination products don't fit into the traditional categories of drugs, medical devices, or biological products, the USFDA is in the process of devel

n EEO specialist will be a welcomed addition to that HR staff. Much larger firms or businesses should of course consider hiring both an EEO specialist and a labor law attorney especially when government contracts are involved.

Co

ping new procedures for reviewing their safety, efficacy and quality.

Professional from academic institutions, pharmaceutical industries, health care indust

rts will generally ask an employer during a discrimination law suit how employment laws are disseminated to their employees. Are they merely posted on a bulletin board (which some are required to be posted) and the employee given

y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products

a handbook to read, or are employees provided this valuable information on the day of hire through an orientation with supplemental training throughout the year? It is in the best interests of an employer to hire experienced EEO p

.

As there is an increasing trend of the combination products companies manufacturing such products should be able to tackle the problems involved in the de

ofessionals and/or legal counsel. Doing so will lessen liability they will likely incur if there are discrimination lawsuits. The bottom line for an employer is that an employer may actually prevent that one damaging lawsuit from

elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

Companies that provide selfless information through particip

occurring. How they do that is by taking the affirmative steps to ensure compliance with the law and applying all of the employment laws with the genuine intent to ensure full equal employment opportunity.

John Paul Fuller, MA, M

tion in industry events and feedback to regulatory authorities would be able to face the challenges and will be successful in developing combination products

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