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Vitale-Sarlo Bill To Regulate Pharmaceutical Wholesalers Advances

TRENTON – A bill sponsored by Senators Joseph F. Vitale and Paul A. Sarlo which would require State regulation of pharmaceutical wholesalers to protect the health and safety of New Jerseyans was unanimously approved by the Senate Commerce Committee today.

“Without State regulation of pharmaceutical wholesalers, New Jersey is vulnerable to attack from counterfeit and possibly dangerous and lethal knock-off drugs,” said Senator Vitale, D-Middlesex, the Chairman of the Senate Health, Human Services and Senior Citizens Committee. “If we allow this industry to continue to operate unchecked, we could potentially be putting the lives of our State’s residents at risk.”

“Currently, pharmacies are subjected to regulation through the State Board of Pharmacy, but no such safeguards exist for the drugs coming into our pharmacies,” said Senator Sarlo, D-Bergen, Essex and Passaic. “We need to have a secure and safe pharmaceutical market in this State, and that means oversight of wholesalers as well as retailers. If we leave this loophole unattended to, we could be facing a serious health crisis in the Garden State.”

The bill, S-1753, would create a regulation scheme for wholesale pharmaceutical distributors. Under the bill, wholesale distributors would be subject to licensure by the State Department of Health and Senior Services, and would be required to undergo a criminal background check.

The bill also requires that the applicant’s facility be available for inspection, and that the distributor designate a representative who is intimately familiar with the day to day operations of the business and can provide information to the department on request.

Senator Sarlo added that a recent bust in Bergen County of a counterfeit prescription drug ring highlighted the need for regulation of wholesale distributors.

“These regulations will help legitimate wholesale distributors by keeping unsafe, criminal competitors out of the market,” said Senator Sarlo. “When you compare the costs of running a safe, above-board pharmaceutical operation with running drugs illegally out of the back of a van, the legitimate business can’t compete. However, with standardized safety requirements for State licensure, the distributors that do business responsibly and ethically will not be disadvantaged by criminals who can charge a fraction for illegally-obtained and sometimes unsafe prescription drugs.”

Senator Vitale argued that without State regulation, drug shortages could potentially be exploited for the profit of dishonest vendors.

“This past year, we read news reports suggesting that profiteers sought to capitalize on the flu vaccine shortage with a dangerous, fake flu vaccine,” said Senator Vitale. “A loophole in licensing requirements which allows exploitative individuals to stock our retail pharmacies with placebos, or potentially worse, needs to be closed. We cannot allow a devious few to, essentially, operate a modern-day snake-oil scam when the health and safety of New Jerseyans is at stake.”

The bill now goes to the full Senate for consideration before going to the Assembly for approval.

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