PEF retiree still serving New Yorkers, assists in the passage of a prescription drug recall notification bill
By KATE MOSTACCIO
When Ron Goldstein, a PEF retiree who served more than 20 years on the PEF Executive Board, found out while surfing the Internet that the Food and Drug Administration (FDA) had recalled his generic version of the prescription blood pressure medication Valsartan, he was understandably upset that he wasn’t notified.
According to the FDA, “the recalled products contain an impurity, N-nitrosodimethylamine (NDMA) . The presence of the potentially cancer-causing NDMA was unexpected, and the agency believes the NDMA is related to changes in the way the active substance was manufactured. Some levels of the impurity may have been in the valsartan-containing products for as long as four years.”
“Not all manufacturers of the widely prescribed drug were involved,” Goldstein said. “Unfortunately, I had been taking one of the affected versions for over three months.”
In the United States, 9 out of 10 prescriptions filled are for generic drugs, according to the FDA.
Goldstein works as a volunteer in the office of Assemblyman Daniel Rosenthal every Friday afternoon and serves as Rosenthal’s PEF Political Action Liaison (PAL). He had an opportunity to effect change — so he spoke up.
“I told him that, in my opinion, legislation was needed requiring pharmacies to notify customers when their prescription medicines are recalled for a major safety issue,” Goldstein said. Being in the office weekly gave him a chance to follow-up. “I would ask, ‘What are you doing with my suggestion?’”
“His staff followed up on my proposal and he introduced a bill to require patient notification by telephone or mail within three days of an FDA Class 1 recall,” Goldstein said.
Assemblyman Rosenthal and Senator Leroy Comrie sponsored the bill, A.4781B/S.5091B. It passed both the Assembly and the Senate. “There didn’t seem to be much opposition,” Goldstein said. Gov. Andrew Cuomo signed the bill into law on October 18.
“Ron Goldstein volunteers his time in our office every week and played a critical role in ensuring New Yorkers are protected against harmful prescription drug recalls,” said Assemblymember Daniel Rosenthal (D-Flushing). “Through personal experience, Ron recognized the gaps in process and brought the idea for this bill to the table. This is a textbook example of how an individual and an idea can make a positive difference for so many people.”
Helping fellow New Yorkers “feels great,” Goldstein said.
“This is particularly good for seniors, who on average take more long term prescription medicines,” he said. “If you buy a car and there is a recall, they have to notify you. Until now, there was no requirement to notify you about medication recalls.”
Goldstein is no stranger to legislation.
He began his 37-year state career with the State Consumer Protection Board. “While in that job, I suggested two pieces of legislation. They made me write it,” he said. Both bills were supported by the Governor and passed the Assembly but died in the State Senate. “Thirty-five, 40 years later, I got finally got a bill through.”
While he didn’t write this legislation, he credits Rosenthal’s staff and the Legislative Drafting Office, he is proud of his role. “It’s a good bill,” he said.
Lobbyists for small drug stores had argued the duty to notify patients should lay with the doctors prescribing the medication, Goldstein said. “The reason that doesn’t work is that your doctor doesn’t know the brand and lot number that you received.” Only the pharmacy has that information. And, like the Valsartan recall, not all manufacturers of a drug may be involved.
The Governor’s Office applauded the bill.
“People deserve to know when a medication that’s supposed to make them feel better may actually make them sicker, and it’s common sense that pharmacies communicate that information to patients in real time,” Cuomo said in a statement.
For those taking medications that are subject to a Class 1 recall impacted by the bill, the FDA advises them not to stop taking their medication without first speaking with their prescribing physician.
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