Advice You - Business

Email is both a blessing and a real annoyance to businesses. It allows you to send a quick message to your clients or to your employees in a branch office hundreds of miles away. But it can also leave y

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

ou vulnerable to viruses that can cause your server to crash, spam that can eat away at huge parts of your day, and can put confidential company information out into public cyberspace. What should you be

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

Examples of combination products may in

doing to protect your business?

1. Mistake #1 – You do not have any policies in place for the use of your email system. If you do not want your employees using company time and company resources to sen

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

pornography, bad jokes, or company secrets, your business needs a written policy that all employees must follow. It must start with who can use the email system and for what purposes. You should consul

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

t your attorney (and you should have a business attorney as part of your team) who can advise you about privacy and compliance issues. The written policy must be distributed to all employees as part of t

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

Combination pro

he employee handbook or on its own if you do not have such a handbook or manual. Its content should be part of the training that all employees undergo when they start their employment with your company.

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

nd your policies should be reviewed once a year to ensure that they are current with the law.

2. Mistake #2 – You do not have any security systems in place for your company’s emails. All of us have expe

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

rienced. Spam wastes hours of your employees’ time, even if they are smart enough to just delete them. They waste even more time if your employees are opening up and reading them. You need security sys

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

tems that will filter out and watch your email so that viruses and spam will find it harder to get through. There are companies that you can hire, or computer hardware and computer software that you can

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

uy. Which form of protection you choose will be a balancing of the size of your company, the size of your tech department (if there even is one) and the amount of money you want to spend.

3. Mistake #3

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

– Your employees use the company email system for private purposes. If your employees are using company’s email system, it is assumed by the recipient of the email that the employee is representing the c

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

Following aspects would a

ompany concerning the contents of the email. But what if your employee is using the company email system for his/her own private concerns and there is a legal problem between your employee and the recipi

dd to the challenges in developing combination products:

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

nt of that email? Your company will be part of any lawsuit that ensues because the recipient of that email has rightly or wrongly believed that your employee was acting as a representative of your compan

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

y. Even if you are able to get your company dismissed from this lawsuit, you have now spent time and money on lawyers to clear your name. And all because you had no policy against your employees using t

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

he company email system for private purposes.

4. Mistake #4 – You monitor your employees’ emails without their knowledge. You are curious about whether an employee is looking to leave the company and ta

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

e company secrets or customer lists with him/her. So you start opening up his/her emails to read them without his/her knowledge. You may have a legal problem, called invasion of privacy, if you have not

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

Professional from academic institutions, pharmaceutical industries, health care indust

created and informed your employees about a policy that permits you to read any and all emails that are sent or received on the company’s email system.

5. Mistake #5 – You have no company policy on stor

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

age of emails. Most companies delete emails after they have been on the computer server for a period of time. But emails are increasingly being used as evidence in lawsuits. Additionally, certain indus

.

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

ries must keep emails, such as the financial and healthcare industries. Your company should have procedures and policies in place as to which types of emails must be retained and archived and which can b

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

Companies that provide selfless information through particip

e deleted.

As a former general counsel of a national mortgage lender, Ms. Gronsky is experienced in corporate matters, mortgage licensing on a nationwide basis, and all facets of real estate transactions

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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