Thu, Sep 18, 2008 16:00 EDT

:PharmaIT Pill: Pharmaceutical Manufacturing-- Eminent Change Needed

Topic: Enterprise Management

Current Rating: Comments: 2

With so many dollars at stake in the industry, it’s no wonder that conventional market influences are putting increasing pressure on manufacturing. Drug pipelines seem more and more inadequate, investors clamor for profits in an increasingly competitive environment, and manufacturing deficiencies can result in unacceptable delays to market, recalls, and legal actions costing millions and millions of dollars. In addition to this, the FDA’s scrutiny of manufacturing operations seems to have increased in recent years even if the frequency of inspections has been reduced. This has resulted in several high-profile cases that have included consent decrees for several big pharmacos for deficient manufacturing practices. This has also caused delays in new drug approvals and caused some drugs to be in short supply. The imminent change in certain markets, like India, from non-regulated to regulated, is likely to require further focus on regulatory aspects. Regulators are changing-- changing their action pattern; how do pharmacos behaving?

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Thu, Sep 18, 2008 22:20 EDT

FDA also focusing more on softwar testing

Posted by: Gordon MacGregor
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In addition to all the traditional worries for medical device, pharma, and biotech firms, the FDA is now cracking down on proof of adequate testing of software used for production of such products.

We spend a lot of time advising firms how to avoid issues in this area. Unfortunately, it is usually after a problem has arisen that we are invoked.

It's not difficult to be in compliance with a little proactive planning, but it takes time and it is very difficult to quickly get into compliance AFTER the FDA comes knocking, without spending an unnecessary fortune. The FDA can and does shut down firms completely until such issues are resolved.

Like all regulatory issues, paying a little attention now can save you a bundle later.

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Fri, Sep 19, 2008 1:05 EDT

Action-Reaction

Posted by: Outsource Opinionist
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Simple law of nature, for every action, there is a reaction.

Due to rising costs of materials and services, many Big Pharma Co's outsource drug research, development and clinical trials to lower-cost regions in the world, such as in Asia.

And because of that, the FDA reacts by implementing and enforcing stricter legislation, prodded on by the backlash and concerns of the regular consumers and interest groups, demanding "Quality for humanity" and "Cheaper" isn't necessarily "Better."

What Pharma Co's can only do is meet the challenges of these stricter FDA regulations and prove their detractors wrong. Given that the farming out of drug research and development isn't the instant cure for Pharmaco's business woes, it can be a step towards it. Though like any good thing, it'll take time and trials--

One other thing Pharmaco's could also do is make the most of their access into the emerging markets and cater to the needs of regional consumers while adhering to the drug quality regulations in those regions. Everybody gets sick, everybody needs good medicine.

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