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    The Podium

    A threat to the state’s biotech industry

    With the unemployment rate steadily decreasing, it appears as if the Massachusetts economy is finally on the rebound. The Bay State’s vibrant life sciences cluster is playing a major role in this job growth.

    More than 53,000 residents of the Commonwealth are directly employed by the biotechnology industry. The typical job in this sector pays 90 percent above the average salary in Massachusetts. And the industry is growing — Massachusetts is among the top three hiring locations in the country for biotech.

    Sadly however, thanks to lawmakers, the industry’s best days could be in the rearview mirror. Right now, our elected officials in Washington are considering a number of proposals that could harm this exciting and vital industry —and stifle future medical breakthroughs.


    Medical innovation is advancing at a remarkable pace. Over just the past decade, biologic medicines have accounted for as many as 42 percent of all new treatments approved by the Food and Drug Administration. And according to a new report, there are currently close to 1,000 new biologics in development, targeting more than 100 different diseases, and many of these medicines are being developed right here in Massachusetts.

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    For cancer patients, the future is particularly bright. Cancer death rates are falling by approximately 1 percent each year and new cancer therapies comprise more than one-third of the medicines in development in the Commonwealth.

    At a time of such remarkable growth and promise, it’s critical that federal and state lawmakers foster a regulatory environment conducive to innovation.

    Biotech firms face huge upfront costs: long discovery and development times, high failure rates, and increasingly complex and expensive clinical trials.

    On average, a company will spend more than $1.2 billion to develop a new drug, which can take up to 15 years to reach patients.


    We need laws and regulations that encourage the development of new medicines. Controlling healthcare costs is an important priority, but it should not come at the expense of medical innovation or safety.

    Unfortunately, some in Washington are pushing policies that could dramatically weaken the biotech industry.

    For example, the White House has proposed altering the Medicare prescription drug benefit, known as Part D. The administration would like to require pharmaceutical companies — a major player in the biotech space — to pay a rebate to the government on all Part D medicines sold to low-income enrollees.

    Though intended to lower federal spending, this system of price controls could possibly raise monthly premiums for beneficiaries between 20 and 40 percent. Not only that, it would undoubtedly make the industry much less attractive to investors thus, costing jobs and stifling research.

    The White House is also pushing to lower the period of data protection afforded new biologic medicines. Under current law, competitor companies cannot gain approval of their own versions of a new biologic medicine for 12 years. This period allows innovator firms to potentially recoup their investments.


    This data protection is critical to ensuring the United States remains a leader in life sciences. Developing a new biologic is an incredibly expensive and time-consuming endeavor. To advance the discovery of new biologic medicines, this protection must be long enough to allow innovators to earn a return on that substantial investment.

    Some in Washington would like to reduce this period to only seven years.

    Doing so would increase uncertainties about medicinal safety and potential returns on new drugs and drive investment dollars — from venture firms and elsewhere — away to other industries.

    These proposals threaten an industry on the verge of historic advancements.

    We can’t allow misguided policies to disrupt and stifle the environment that has helped biopharmaceutical innovation flourish.

    Our congressional delegation has done great work to advance the growing biotech industry in the Commonwealth. Our future depends on everyone supporting a move toward more affordable solutions for biologics, but with an approach that ensures the incentive to invest in research in not tempered or discouraged. If Massachusetts is to remain a leader in the life sciences, our Congressional leaders must recognize that price controls on Part D and weakened data protection are the wrong approach. The Massachusetts biopharmaceutical industry has withstood the toughest of economic times; let’s not allow shortsighted policies to impact its survival.

    Kelly Thompson Clark is president & CEO of the Cambridge Chamber of Commerce and co-chair of We Work for Health Massachusetts.