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FDA seems to take light approach to Allergan and LAP-BAND

In 1960, a young inspector for the Food and Drug Administration faced down a powerful drug company by rejecting its application to sell a morning-sickness drug in the United States. The company, Richardson-Merrell, griped about her repeated demands for more safety data. They complained to her superiors, branding her as a nitpicker. But she stood firm. The drug in question was thalidomide, and worldwide as many as 12,000 children were born with severe birth defects after their mothers used it. In the U.S., where Frances Kelsey blocked Merrell from distributing the drug except to a few doctors for "experimental" trials, the toll was 17. Today’s FDA isn’t that FDA.

Today's FDA can be steamrollered. Today's FDA just approved an application by Allergan to expand the target market of its Lap-Band weight-loss device potentially by tens of millions of patients. How much safety data did the FDA review before giving Allergan the green light? Mainly the results of one year of study of 149 patients. Kelsey has said that she demanded more information from Merrell, thalidomide's U.S. manufacturer, because its history of conflicts with the agency made her suspicious. Is there any reason to mistrust Allergan? Let's look at the record. In September, Allergan pleaded guilty to one criminal count and paid $600 million in fines and penalties to settle federal charges that it had illegally marketed Botox for uses the FDA hadn't approved. In accepting the plea bargain, the government charged that the company had made under-thetable payments to doctors who used Botox to treat unapproved conditions, created front groups and websites to push the broader uses of the drug while concealing Allergan's backing, and coached physicians to over-diagnose a condition for which Botox could be legally marketed so it could sell more product. Allergan took these steps, the government contended, because the approved uses had meager sales potential. The most prevalent condition for which Botox treatment was approved, cervical dystonia, is a neck spasm that affects only about 27,000 people. Allergan wanted doctors to prescribe Botox for headaches. Botox's sales grew 1,407% and by 2007, total Botox sales exceeded $500 million. More than 70% of that was for unapproved uses.

This didn't seem to enter into the FDA's review of Allergan's application to expand its marketing of the Lap-Band, a device that's surgically implanted around the stomach. So far, the approved use has been for morbidly obese people. An FDA advisory panel, which gave preliminary approval to Allergan's application, wasn't entirely happy with the company's data supporting its safety and efficacy claims for the Lap-Band — its own 149-patient study and six other studies, at least three of which conducted by researchers with financial links to Allergan — but they felt that the Lap-Band's benefits outweighed the risks.

(HILTZIKLOS, M., Adapted from Los Angeles Times, 22/02/2011)

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