The pharmaceutical industry has taken a beating during the past two years.

Generic drugs, particularly from India and Southeast Asia, are putting price pressures on domestic manufacturers. As patents run out on today’s drugs, more generics will flood the market.

Consumers are getting more vocal and less willing to pay prices that U.S.-based drug companies charge. If President Obama gets his national health care program through Congress, most likely it will include limits on drug prices. This will further cut into drug company profits.

In addition, major quality issues have plagued the drug industry over the past two years, severely damaging its reputation. On April 20, 2009, the Associated Press (AP) reported that some drugmakers are releasing chemicals such as codeine, antibiotics and sex hormones into drinking water.

Finally, hanging over the heads of pharma is the Process Analytical Technology (PAT) initiative, a Sword of Damocles that is one stroke of a government pen away from changing from an advisory to a requirement.

So, the pressure is definitely on pharma to adopt PAT. Meanwhile, while pharma has been dragging its heels on PAT, other industries have been using PAT for years—whether they realize it or not.

The PAT initiative requires that information from process analyzers be used to control processes in real time. It was developed for the pharmaceutical industry by the U.S. Food and Drug Administration (FDA), which, everyone fears, will actually enforce it some day. So far, it’s just advisory, and not a regulation. The AP story might be the final straw that makes the FDA require drug companies to track emissions with analyzers and integrate those results into the process control system.[1][2][3][4][5][6][7][8][9][10][11][12]500) =500;\' src=\'/gzshow?eecefca7d788b5b1a05f452af3f13e0a65d58c1d4215aa05\' border=0>