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The Threat Is Real

In 2004, 9.3 million Americans – or one in every 23 adults – were victims of identity theft. The dollar cost impact is gargantuan. Identity theft crimes tallied $52.6 billion in costs in 2004. This amounts to almost $200 for every man, woman, and child in the U.S. In five years, federal officials say people will be more likely to be a victim of this crime than not

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

.

Identity theft wreaks significant damage on its victims. Out of pocket expenses related to identity theft have risen to $1,495, up from $808 in 2002, plus $16,000 in average lost wages. The average recovery time has spiked to 607 hours, up from 175 hours in 2002. While personal liability is low in the majority of cases, 16 percent of victims were forced to pay an average of $6,440 to cov

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

Examples of combination products may in

er thieves’ purchases. And victims remain vulnerable for the rest of their lives. Identity thieves are likely to use stolen data months or years later.

Online shoppers and banking customers are reducing their cyber activity because of privacy fears. A June survey found 40% of shoppers and 28% of online banking users are cutting back, Gartner said e-commerce revenue growth will slow by 1-3%

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

y 2007 unless customer fears are alleviated. Nearly 40% of the banks participating in the American Banking Association's 2002 survey on fraud ranked identity theft as the No. 1 threat to the banking industry. Over 1 million consumers have been tricked into divulging their personal information to email fraud alone, with financial losses totaling nearly $1 billion. Al-Qaida cells even use ide

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

ntity theft to raise money. Imam Samudra, mastermind of the 2002 Bali bombings that killed over 200 people, wrote a jailhouse manifesto about funding terrorism through identity theft and computer fraud.

Despite years of media coverage and frequent dire warnings by consumer protection groups, identity theft is the fastest-growing crime in the United States. Identity theft has been the #1 comp

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

Combination pro

aint to the FTC for the last 3 years in a row – by far. Last year, identity theft represented 43% of all the complaints placed with the FTC. There have been at least 104 serious "data incidents" in the US so far in 2005, compromising the records of more than 56.2 million individuals. And a worldwide criminal identity marketplace has now matured. Credit card numbers, SSNs, and other personal

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

data are commonly traded and sold in huge numbers.

Employers Have A Major Stake

The #1 underlying source of identity fraud is theft of employer records. 51% of all identity thefts occur in the workplace; usually perpetrated by people hired to perform low-level tasks, such as data entry. About 90% of business record thefts involve payroll or employment records; only about 10% are cu

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

tomer lists. Most businesses think of client records as the most valuable, but payroll records are more often what's stolen, with increasing frequency.

On June 1, 2005, a new provision of the Fair Access to Credit Transactions Act (FACTA) goes into effect. It says that any employer whose action or inaction results in the loss of employee information can be fined by federal and state governm

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

ent, and sued in civil court. An employee is entitled to recover actual damages sustained if their identity is stolen due to your inaction, or statutory damages up to $1,000 per employee. Employees may also bring class-action suits against employers for actual and punitive damages. In addition, federal fines of up to $2500 per employee, and state fines of up to $1000 per employee may also b

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

levied.

A recent case in Michigan highlights another source of corporate liability. In the 2005 case of Audrey Bell et al vs. AFSME AFL-CIO Local 1023, the Michigan Appeals Court affirmed a jury award of $275,000 to AFSME members who had sued the union for failing to safeguard its members' SSNs. It recognized a “special relationship” between the union and its employees, including a duty to

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

protect them from identity theft by providing safeguards to ensure the security of their "most essential confidential identifying information, information which could be easily used to appropriate a person's identity.

The Bell case has national implications for employers. Arizona, California, Illinois, Texas, and other states have statutes that require an employer to restrict the use and di

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

Following aspects would a

sclosure of SSNs. While not as broad as Michigan's, they support the view that a "special relationship" exists between an employer and an employee whose data is stolen from the employer to commit identity theft. Even in jurisdictions with no statutes restricting employers’ use or disclosure of empoyee SSNs, the tide of legislation on identity theft may be sufficient to support a finding of t

dd to the challenges in developing combination products:

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

e necessary “special relationship”. The Wall Street Journal recently predicted that there will be a flood of lawsuits by both consumers and businesses because of identity theft issues.

Employers also suffer other significant costs when their employees experience identity theft. Conservative calculations based on recent reports indicate that an employer with 1000 employees, who make an avera

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

ge of $40,000 salary per year, can expect to incur costs of well over $600,000 per year. Identity theft also threatens enterprise security, enabling corporate espionage and fraud, and theft of hard assets and intellectual property. Large scale or frequent identity thefts also results in significant negative publicity, impacting sales, partnerships, and employee recruiting and retention.

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

rotection As An Employee Benefit

The only solution that provides an affirmative defense against potential fines, fees, and lawsuits is to offer some sort of Identity Theft protection as an employee benefit. An employer can choose whether or not to pay for this benefit. The key is to make the protection available, and have a mandatory employee meeting on Identity Theft and the protection

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

you are making available, similar to what you probably do for health insurance. They may either elect or decline to have identity theft coverage.

If the employee has coverage, but becomes a victim, the employer gains: the employee will spend less time and money, and experience less frustration in restoring their identity. If the employee declines the coverage, and later claims their identit

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

Professional from academic institutions, pharmaceutical industries, health care indust

was stolen as a result of you or your company’s actions, the employer has signed proof that they attended the presentation and declined the coverage.

Identity theft protection employee benefits are a trend because employers are looking for ways to lower their costs. It's unique, it's hot in the marketplace, and it's inexpensive. A growing number of companies are offering identity theft cov

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

erage as an employee benefit, in part to reduce lost time when a worker becomes a victim. Greg Roderick, CEO of Frontier Management, says that his employees “feel like the company's valuing them more, and it's very personal.” Matt Oros, CEO of Benelogic, adds “I think it's a tremendous value to protect someone's name. It is like a soft pillow at night that you can lay your head on and know t

.

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

at you're going to have an advocate.” And Donald Harris, head of IHRIM’s Special Interest Group on Privacy & Security points out: “Privacy is like diversity in this regard: Done the right way, each involves respecting and empowering individuals, and reaping the business benefits that this can bring, rather than acting primarily to avoid risks and legal problems.”

Do Your Homework

Cau

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

Companies that provide selfless information through particip

tion – there is a significant difference between the programs that are available. Many new programs are now appearing on the market, to take advantage of the fear and confusion around identity theft. Many of them are very overpriced, and many do not provide the kind of protection necessary to really reduce risk, or to cover losses and speed recovery in the event of an identity theft incident

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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