Advice You - Business

We've all read bang-up letters to the editor focused on a recent event or issue covered by a publication or TV or radio coverage. More recently, I've seen letters crafted in response to websites and e-newslett

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

ers. It's much more likely that your organization's letter will run than it is to place an op-ed piece or get your nonprofit covered in a feature article.

Unlike news stories, letters to the editor enable you

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

Examples of combination products may in

r nonprofit or foundation to state an opinion, offer an alternative viewpoint, heap praise, or move someone to action, in your own words. That means there's a much smaller chance that the facts will be wrong o

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

r that your message will be twisted or diluted as it might be in a news or feature story written by a reporter.

The benefits for your nonprofit include:

Keeping its name in front of the public.

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

i>Raising its profile.

Getting your share of news ink.

But writing an opinion letter that gets published and has the desired impact is both an art and a science. Here are 10 practical tips

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

Combination pro

for writing a letter to the editor that gets published and read:

Identify your target publications and programs

Select five to 10 venues to focus your opinion letter placemen

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

t efforts on. Don't forget trade publications, and community and weekly newspapers. Depending on your audience, those venues can have greater influence than an opinion letter in the NYT. And it's easier to get

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

letters to the editor published in these smaller publications.

Once you have your target list, you're ready to respond when an opportunity surfaces.

Research the letters policy for each venue

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

on for your target listMost publications and programs publicize what they want in a letter to the editor, and how and to whom to send it. Examples include:

Asheville (NC) Citizen Times – c

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

onditions for rejection http://orig.citizen-times.com/service/faq/letters_policy.shtml

Chronicle of Philanthropy – via snail or email http://philanthropy.com/about/letters.htm

The New York Times – maximum of

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

150 http://www.nytimes.com/top/opinion/editorialsandoped/letters/

The Washington Post – letters must be exclusive to the Post http://www.washingtonpost.com/wpsrv/edit/letters/letterform.htm

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

Following aspects would a

eference a recent print or broadcast articleWrite your organization's letter as a direct response to recent coverage, building on the focus presented or emphasizing how your organization's p

dd to the challenges in developing combination products:

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

erspective wasn't presented (and presenting it clearly).

Respond as quickly as you can.

If there's an issue or news story that's getting a lot of attention in the press, draft

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

a letter or at least key message points so your nonprofit is prepared to finalize and submit your letter pronto.

Hone your opinion letter writing style, before you're on deadline to submit it.

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

/strong>Read letters in your target venues on a regular basis to learn how to write the most effective letter.
Be Concise.
Include a maximum of 200 words. The public

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

ation will shorten your letter to fit its format. The more it has to edit, the less control you have of what gets printed.

Include two to three paragraphs, each with no more than three sentences.

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

Professional from academic institutions, pharmaceutical industries, health care indust
rong>State Your Point Early and Clearly

Use the inverted pyramid scheme, leading with (and maintaining focus on) your most important point.

Include Your Contact Information
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
rong>

Your contact information is a prerequisite for most publications to print your letter. Include your full name, title, organization name, address, phone number and email at the top of the page an

.

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

d sign the letter at the bottom.

Don'ts
Don't write too often. Once every three months is as often as you should write. Avoid being abusive or strident.
Follo

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

Companies that provide selfless information through particip

w UpMake a follow-up phone call to the editor in question to make sure your letter has been received. It's best to keep calling until you get through, rather than leaving a voicemail message

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 You - How to Write a Letter to the Editor that Gets Published and Read

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