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In today’s workplaces, employees are increasingly viewed as a company’s most valuable resource, the key to gaining a competitive advantage. Workplace flexibility, including paid leave, is often viewed as an important tool for getting there. Yet, the low-income workers in the ever-expanding service industry too rar

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

ely are in jobs that offer essential flexibility. The Washington, DC-based Center for Law and Social Policy (CLASP) is part of a growing number of entities working to change that.

Emphasizing the fact that the United States is not among the 139 nations that already offer paid leave for short- or long-term illness

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

Examples of combination products may in

es, the group is one of 56 organizations – including the National Partnership for Women & Families, AFL-CIO, NAACP and the United Auto Workers – that wrote to the U.S. Congress earlier this year in support of a bill currently in the Senate, the Healthy Families Act (HFA). Introduced by Sen. Edward Kennedy (D-MA) a

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

nd Rep. Rosa DeLauro (D-CT) in 2005, the bill calls for a minimum number of paid sick days for employees.

If the HFA became law it would provide for seven paid sick days for full-time workers and a pro-rata amount for part-time workers who work at least 20 hours a week. Firms with fewer than 15 employees would no

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 be obligated to comply. Finally, no changes would be required of organizations that already have adequate paid sick days in place.

Why is this issue so important? The U.S. Bureau of Labor Statistics and the Institute for Women’s Policy Research have found that about half of all private-sector employees don’t ha

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

Combination pro

ve access to a single paid sick day. Jodie Levin-Epstein, deputy director of CLASP, points to an even larger dilemma affecting low-income parents that was uncovered by The Urban Institute. “Forty-one percent of low-income parents below between 100 and 200 percent of the poverty level don’t receive any kind of paid

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

time off – no paid sick time, no paid vacation time and no paid personal time,” she says. “This shows that low-wage families are working on a tightrope.”

CLASP’s work in support of the measure emphasizes workplace flexibility, both for the employee and the employer. The group takes the stance that employers that

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

offer employees flexible scheduling can experience a wider range of benefits, including greater employee retention and productivity, as well as lower health care costs. In fact, the Institute for Women’s Policy Research released a study in support of the HFA which found that if workers were provided seven paid si

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

ck days a year – the same number of days for full-time workers proposed in the HFA – the net savings to our economy in the form of reduced turnover, higher productivity and fewer illnesses in the workplace would be over $8 billion per year.

Levin-Epstein says that the practice of “presenteeism,” wherein workers 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

ome to work while ill, contributes heavily to the spread of illnesses in the workplace. Under the HFA, however, she says that this practice has the greatest chance of being substantially reduced. Lindsey Lee, the owner of Cargo Coffee in Madison, Wisconsin, agrees. “Employees working sick are not working effective

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

ly,” Lee says. “I’ve had periods where it seemed like a domino effect,” referring to employees making other employees sick.

For some small business owners, financial limitations make it impossible to provide health care coverage for their employees. In light of this, paid time off for illness has become a both a

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

Following aspects would a

viable and desirable option. “There are other independent restaurants nearby. My employees could very easily go and get a job elsewhere,” says Barbara Wright, who owns a Mediterranean restaurant in Madison called The Dardanelles. “[Paid sick days] are the only thing I can offer, the only thing I can afford.” Wrigh

dd to the challenges in developing combination products:

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

t reports that this attempt to promote a greater work/life balance has boosted her staff’s morale. Lee has seen a similar boost in morale among his staff. “It’s a benefit they don’t expect, but are happy to get,” he says.

Carla Cohen, who manages Politics and Prose, a bookstore in Washington, DC, says, “Paid sick

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

days is affordable if the owners care about their business over the long haul and not just about pulling out as much money as they can.” Cohen sees the practice as mutually beneficial to her employees, her store’s sales and her customers. “Our objective is to have employees remain with us as long as possible beca

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

use we give better customer service that way,” she says. “People come to us to buy books rather than a chain where the employees do not know anything.”

The bookstore offers a minimum of three weeks of paid vacation and leave for every employee working more than 24 hours a week. The amount of paid time off increas

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

es the longer an employee works there. The result, Cohen says, has been remarkable retention: Of 60 mostly full-time employees, a dozen have been with the bookstore for 10 or more years, and another 20 employees have worked there for between five and 10 years.

These businesses are similar in a number of ways: The

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

Professional from academic institutions, pharmaceutical industries, health care indust

y offer paid leave for sick days, they value their employees as a resource, they are flexible and they are successful. These are the enterprises that CLASP and the other groups behind the HFA point to as examples of better workplaces made possible through the development of paid sick leave practices. CLASP and a g

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

rowing number of groups are hoping that the U.S. will join the roster of nations that recognize the benefits of implementing paid sick days for businesses, their workers and society at large.

Paid Sick Leave: Additional Resources

CLASP: “Getting Punched” (pdf) http://www.clasp.org/publications/

.

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

getting_punched_fullnotes.pdf

Institute for Women’s Policy Research http://www.iwpr.org/index.cfm

National Partnership for Women & Families http://www.nationalpartnership.org/

The Urban Institute http://www.urban.org/

Sample Legislation

City of Madison, WI (pdf) http://legistar.cityofmadi

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

Companies that provide selfless information through particip

son.com/attachments/4247.pdf

State of Maine http://janus.state.me.us/legis/LawMakerWeb/externalsiteframe.asp?ID=280015993&LD=%091044&Type=1&SessionID=6

Commonwealth of Massachusetts http://www.mass.gov/legis/bills/senate/st01/st01130.htm

Federal: Healthy Families Act – Senate Bill S.932 http://thomas.loc.gov

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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