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Advice You - Ten Media Crisis Tips
No comment. These are probably the two most damaging words in the English language to the reputation of a professional, business or organization. While positive publicity is 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
lways wanted, what happens when bad publicity comes your way?
One day damage control is bound to be necessary. It might be a lawsuit. Maybe an accident at your place of busin
One day damage control is bound to be necessary. It might be a lawsuit. Maybe an accident at your place of busin
; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.
Examples of combination products may in
Examples of combination products may in
ess. Or perhaps a labor dispute. Want it or not, a crisis will bring the media to you and thrust you into the spotlight.
Often the first reaction is to say "no comment." This
Often the first reaction is to say "no comment." This
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
is the worst thing you could ever say, short of a full admission of wrongdoing. Such a comment is condemning, as it implies you have something to hide. The news media and the
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
public will assume you are guilty.
If your goal is to postpone comment until you assemble the facts, there is another phrase you can use. When asked to comment before you are
If your goal is to postpone comment until you assemble the facts, there is another phrase you can use. When asked to comment before you are
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
ready, say this instead: "It would be premature to speculate at this time." Tell the media that you are greatly concerned about the issue, it has assumed top priority, and al
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
l resources are being used to assess the situation.
Many reporters will admit privately that you will be treated much better by the media if you use this approach. Look at th
Many reporters will admit privately that you will be treated much better by the media if you use this approach. Look at th
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
world through their eyes. They are on a deadline to produce a story. Even if all you can say is that it's premature to speculate, you are helping them out.
If the situation
If the situation
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
is ugly, by all means get professional public relations help. You are about to be tried in the court of public opinion. Abraham Lincoln said that a person who defended himself
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
in court had a fool for a client. You wouldn't go to a court of law without legal counsel. Don't go into the court of public opinion without competent counsel as well.
In de
In de
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
ling with the media during a crisis, here are 10 specific steps to follow:
1. Provide media with access to top executives. A senior executive must represent the organization.
1. Provide media with access to top executives. A senior executive must represent the organization.
ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.
Following aspects would a
Following aspects would a
Someone who sets policy will carry the most weight.
2. Never say "no comment," even for sensitive legal or HR matters. Instead say: It is not our policy to comment on pendin
2. Never say "no comment," even for sensitive legal or HR matters. Instead say: It is not our policy to comment on pendin
dd to the challenges in developing combination products:
Which markets to tap where the combination products can do fairly well?
Which combination prod
Which markets to tap where the combination products can do fairly well?
Which combination prod
g legal actions, except to say we think this is without merit and we will defend ourselves vigorously.
3. Know your rights as an interviewee. Agree on the ground rules up fro
3. Know your rights as an interviewee. Agree on the ground rules up fro
cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin
nt. Insist on time to prepare, no matter how hastily.
4. Prepare, prepare, prepare for media interviews. Have three points. Rehearse taking questions. If possible, tell the w
4. Prepare, prepare, prepare for media interviews. Have three points. Rehearse taking questions. If possible, tell the w
tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
ole story at once, rather than keeping it alive in the media while additional facts are uncovered.
5. Be open, candid and non-adversarial. Withholding information or evading
5. Be open, candid and non-adversarial. Withholding information or evading
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
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
questions will always backfire. This will look like an attempt to cover up incompetence, or worse, malfeasance.
6. Present information from the viewpoint of the public intere
6. Present information from the viewpoint of the public intere
ping new procedures for reviewing their safety, efficacy and quality.
Professional from academic institutions, pharmaceutical industries, health care indust
Professional from academic institutions, pharmaceutical industries, health care indust
st, rather than from the corporation's interest.
7. Respond to all media inquiries. Avoid the appearance of dodging media inquiries. You will be treated worse. Much worse.
8
7. Respond to all media inquiries. Avoid the appearance of dodging media inquiries. You will be treated worse. Much worse.
8
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
Never speculate. Guesswork can be reported as fact. Don't create expectations you will be held accountable for in the future.
9. Remember past performance when developing re
9. Remember past performance when developing re
.
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
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
sponses. Your past record of positive achievements will serve you well during a crisis. Stress positives where appropriate.
10. Sometimes start with a prepared statement. Exp
10. Sometimes start with a prepared statement. Exp
elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.
Companies that provide selfless information through particip
Companies that provide selfless information through particip
lain the situation, concern and solution. Tell the truth without being too expansive -- then be quiet. Wait for the press to ask questions before going into unnecessary detail
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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