Advice Pool - Legal

E-mail conversations are a pervasive part of our culture. Most people, even in a professional setting, will click the “send” button without even both

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

ering to run a spell check. We probably all have been guilty of treating e-mail like normal, everyday conversation, despite the fact that it can leav

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

Examples of combination products may in

a permanent record of our words.

E-mail conversations between board members of a Massachusetts charter school hold a hidden danger as their intercha

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

nge could unknowingly constitute a violation of the Open Meeting Law.

The Open Meeting Law, M.G.L. Ch. 39, §§ 23A and 23B, applies to meetings of all

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

governmental entities on the state and municipal levels, including the board of trustees of a charter school. The laws ensure that almost all meeting

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

Combination pro

s of state and municipal governmental bodies are noticed to the public and open to any citizen who wishes to attend. In other words, any official del

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

beration of governmental action must take place in a public meeting and must include a public record of any action taken.

The Attorney General’s Offi

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

ce has offered guidelines that any electronic communications between a quorum of board members engaged in deliberation of substantive issues may viola

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

e the Open Meeting Law, “as the public is deprived of the opportunity to attend and monitor the e-mail ‘meeting.’” This would include e-mails, chat r

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

ooms or board-only bulletin boards.

In the Massachusetts charter school context, any e-mail interchange between the board of trustees could violate t

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

e Open Meeting Law if: 1) the number of members included on the interchange constitute a quorum as defined by the board’s by-laws; and 2)<

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

Following aspects would a

/b> the discussion is a deliberation about action to be taken by the board.

Can board members discuss anything over e-mail with each other? Yes, the

dd to the challenges in developing combination products:

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

Attorney General’s Office does recognize the efficiency of electronic e-mail in connecting board members together for topics like scheduling (assuming

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

in the end that notice of the meeting is given per usual). Also, e-mail can be useful in distributing literature and advance copies of agendas, so t

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

at the board members can be prepared on the issues to be discussed.

The board must be careful, however, that no arguments are made for any course of

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

action and certainly no decisions are made in advance of a noticed public meeting during the course of serial e-mails between the members. The board

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

Professional from academic institutions, pharmaceutical industries, health care indust

hould also print and save a hard copy of any e-mails between board members to be made available as a public record upon request. To fail to do either

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

, may invite a costly investigation by the Attorney General’s Office.

So the next time you reply on an e-mail to the whole board, you may want to thi

.

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

k twice before you hit “send!”

This commentary is not intended as legal advice. For advice on a specific case, you should contact the attorney direc

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

Companies that provide selfless information through particip

tly. Pursuant to Rule 3:07 of the Supreme Judicial Court Rules of the Commonwealth of Massachusetts, this communication may be considered advertising

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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Advice Pool - The Open Meeting Law - What Every Charter School Board Member Needs to Know About E-mail Lists

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