What Would a Reformed FDA Mean for Big Pharma?

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Over the past several years, a wave of recalls of contaminated pet food, tainted spinach, and toys containing lead paint have put product safety firmly on the legislative and regulatory radar screen.

The 2008 passage of the Consumer Product Safety Improvement Act initiated the most sweeping reform of the Consumer Product Safety Commission in the agency' s history. Now, with a new administration taking the reins in Washington, the Food and Drug Administration may be next in line for reorganization and reform.

In recent years the FDA has faced a growing chorus of criticism in the wake of international recalls of the blood thinning drug Heparin and baby formula contaminated with melamine, along with a number of other high-profile product safety issues involving food and medicine.

If the agency is, indeed, in line for a makeover, the implications for food and pharmaceutical companies would be considerable, but not necessarily negative, as long as industry takes an active role in the process.

Pharmaceutical companies have complained for years about the increasingly slow pace of FDA drug approvals and the agency' s increasingly risk averse approach. They claim that FDA bureaucrats are, at best, a roadblock to innovation and, at worst a danger to patients who would benefit from new drugs that are stuck in the approval pipeline.

But even the FDA' s harshest critics concede that the agency has been asked to do more and more every year without any significant increase in staff or funding. Along the way, the agency has become an increasingly popular target for politicians looking to grab a quick headline whenever a new recall crisis erupts. In the coming months, growing political pressure could make what is already a sluggish and burdensome drug approval process even slower - giving new meaning to the saying "no bureaucrat ever got fired for something he or she didn' t do."

But on the flip side of that coin, increased funding for the FDA could mean more resources for drug approval. And that would be a big win for Big Pharma. Increased Congressional attention to the FDA offers the industry a golden opportunity to make its voice heard in the debate over the agency' s authority and funding. The industry' s wish list is long, but not necessarily out of sync with that of congressional reformers. If congressional critics of the FDA are willing to stop criticizing the agency and instead clarify its authority and give it the resources it needs to do its job, everybody wins.

But the window of  opportunity for the industry won' t stay open forever.  The new Congress is ready to act. The industry needs to be ready to weigh in as a partner rather than an adversary.

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