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Miami Herald
Miami Herald
Business
Tom Hudson

The Week Ahead: Is this the medicine drugmaker stocks need?

The political media may be focused on Donald Trump's Twitter feed and the lobby of his building in midtown Manhattan. But over on Capitol Hill, Congress is passing legislation.

And a bill that will head to the Senate in the week ahead could have far-reaching implications for drugmakers, companies that creative medical devices and investors.

The wide-ranging, 1,000-page bill, called the 21st Century Cures Act, is described as the biggest health care reform legislation since the Affordable Care Act, aka Obamacare.

It includes billions of dollars for new medical research and fighting the opioid addiction crisis. But its most controversial sections aim to streamline the drug approval process for medicine makers.

Critics of the current Food and Drug Administration approval process say it's slow, cumbersome and expensive, delaying innovative medicines from the market and inflating their cost to patients and insurers.

Among the changes in drug trials, the bill would lower the bar for indicating a medicine's effectiveness. It would also allow drug trials with fewer people and simplify studies. The upside, supporters argue, include cheaper experiments and faster approval. The risks are less exhaustive studies on a drug and its potential dangers.

It's no surprise drugmakers like the legislation.

Major medicine makers always are on the hunt for the next blockbuster drug _ the next Prozac, Lipitor or Viagra, for instance.

Those drugs represented billions of dollars of profits for their makers and shareholders when they were released and under patent.

Opponents of the bill worry that lowering the bar for scientific evidence necessary to bring a new medicine to the market presents a public health risk.

Pharmaceutical shareholders should know their investments are only as strong as a company's pipeline of new, and profitable, medicines. The speed of that pipeline may change considerably in the week ahead.

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