FDA commissioner: Agency to revamp enforcement system
ROCKVILLE, Md. With a new administration and a new commissioner, the Food and Drug Administration plans to step up enforcement.
FDA commissioner Margaret Hamburg announced Thursday a plan “to prevent harm to the American people” through “swift, aggressive and effective” enforcement of FDA laws and regulations. Hamburg said that some FDA enforcement actions over the past several years have been subject to delays, resulting in serious violations going unaddressed for long periods of time.
Under Hamburg’s plan, the agency will take six initial steps to change the agency’s enforcement system. These include clear deadlines for responding to FDA inspection findings; speeding up the warning letter process; working more closely with other regulatory agencies; prioritizing follow-up on enforcement actions; being prepared to take immediate action in response to public health risks; and developing a formal warning letter “close-out” process for when a company has corrected violations.
“The FDA must be vigilant, the FDA must be strategic, the FDA must be quick, and the FDA must be visible,” Hamburg told attendees of a speech sponsored by the Food and Drug Law Institute in Washington. “WE must get the word out that the FDA is on the job.”
Merck, Schering-Plough settle Vytorin, Zetia suits
WHITEHOUSE STATION, N.J. Merck & Co. and Schering-Plough Corp. announced Wednesday that they had resolved class-action lawsuits over the purchase and use of two cholesterol drugs.
The companies announced they would pay $41.5 million in suits over the drugs Vytorin (ezetimibe and simvastatin) and Zetia (ezetimibe) to plaintiffs representing consumers, insurers and other groups.
“These agreements will allow the companies to avoid continuing defense costs and remain focused on discovering, developing and delivering novel medicines and vaccines,” Merck general counsel and EVP Bruce Kuhlik said in a statement.
The companies said the settlement resolves all the 140 suits that seek economic damages related to the purchase of Vytorin — which Merck and Schering-Plough market under a joint venture — and Zetia pending in the U.S. District Court for the District of New Jersey.
The lawsuits also made allegations about the safety and efficacy of the drugs based on a clinical trial, though the companies said the settlement is not an admission of liability on that matter or an admission of misconduct or liability in connection with the marketing or sale of the drugs.
“We continue to believe that Vytorin and Zetia, in addition to a healthy diet, can provide important benefits for physicians in helping their patients with high cholesterol reach their cholesterol goals,” Schering-Plough EVP and general counsel Thomas Sabatino said.
CVS Caremark mum about possible Aetna PBM purchase
CHICAGO CVS Caremark’s CFO Dave Rickard is keeping quiet on whether the corporation is interested in buying Aetna’s pharmacy benefit management business.
Acquiring Aetna’s PBM business would give CVS Caremark further expansion in the pharmacy benefits business, though the company is busy integrating retailer Longs Drug Stores, which it bought last October.
Despite being rumored as one of the potential buyers along with Medco Health Solutions, CVS Caremark has not disclosed whether the company will take advantage of the offer.
“We are in a position that if something that was very important strategically came along we could act on it. If that were available and the terms were right and the price was right then I think we’d have to look at it,” said Rickard.