Vermont to Sue FDA Over Drug Reimportation

first_imgGovernor & Attorney General to Sue FDA Over Drug ReimportationMontpelier, Vt. — Governor Jim Douglas and Attorney General WilliamSorrell announced August 10 that Vermont will file suit against the Food andDrug Administration (FDA) in U.S. District Court over the issue ofimporting drugs from Canada. Vermont is the first state in the nation tosue the FDA for blocking a responsible reimportation proposal.Vermont had sought a waiver from the FDA authorizing a legal drugreimportation plan. The goal of the pilot project was to demonstrate howa plan could be safely implemented, and ultimately serve as a model forother states to implement similar programs.Douglas and Sorrell agreed the suit was necessary, saying the federalgovernment’s grounds for denying the waiver request are illegitimate.”Vermont presented a legal and responsible plan to import prescriptiondrugs,” Governor Douglas said. “The claims on which they’ve based thisdenial are, in our view, unsubstantiated and we have no choice but topursue any and all legal remedies available. We intend to file suitshortly against the FDA in federal court.””Vermont’s petition was carefully crafted and reasonable,” said Sorrell.”I am amazed that the FDA rejected it, but am looking forward to gettingthis in front of a federal judge.”In response to the FDA’s rejection letter, Administration SecretaryMichael Smith sent a strongly worded reply voicing the administration’sdispleasure at the decision, and informing the FDA that Vermont would befiling a lawsuit.”Your failure to promptly issue regulations to provide for the safeimportation of prescription drugs from Canada, in accordance with section1121 of the Medicare Prescription Drug Improvement and Modernization Actof 2003, has compromised the ability of any state to adequately addressthis important issue,” Smith said in the letter. “We are, therefore,forced to consider development of a reimportation program that conforms toour interpretation of the current laws, independent of your agency.”In addition, Governor Douglas said he would dispatch the Commissioner ofHealth, Dr. Paul Jarris; Commissioner of Human Resources, Cindy LaWare;and his Legal Counsel, Susanne Young, to review New Hampshire’s plan andpursue a multi-state strategy to assist individuals who want to purchasedrugs in Canada.Governor Douglas noted that reimportation is not a long-term solution andsaid he would continue to urge Congress to take immediate action to reformthe American pharmaceutical marketplace.”Congress should act immediately to legalize the reimportation of lowercost drugs from Canada, increase competition among brand namemanufacturers, speed the approval of generic drugs, preserve states’ability to pool their purchases and negotiate deep discounts withmanufacturers, protect state pharmaceutical programs that may be impactedby the new Medicare law, and review recent increases in the cost ofpharmaceuticals,” Douglas said. “The ultimate goal, of course, is to getthe best deal possible for Vermonters on their prescription drugs at localpharmacies here at home.”Attorney General Sorrell serves as the President of the NationalAssociation of Attorneys General. At that association’s recent annualmeeting, Sorrell announced his presidential initiative to study andrecommend actions in response to the high cost of prescription drugs inthe United States. In commenting on today’s developments, Sorrell stated:”This action by the FDA underscores that, unless we take aggressiveactions, we are going to continue to pay the highest prescription drugprices in the industrialized world.”last_img read more

4 West Islip Men Charged With Armed Home Invasion

first_imgSign up for our COVID-19 newsletter to stay up-to-date on the latest coronavirus news throughout New York Four men were arrested for allegedly committing an armed home invasion during which two victims were assaulted in the suspects’ hometown of West Islip over the weekend, Suffolk County police said.Charged with first-degree burglary were Joseph Cardona, Edward Flaherty and Thomas Hillier, all of whom are 18, as well as 20-year-old Frank Fabozzi.Police said the foursome entered a Bay Shore Avenue home, struck two people inside with a bat and stole items before they fled at 2:50 a.m. Sunday.A victim called 911 and officers apprehended the suspects shortly later, police said. The two victims were taken to a local hospital for treatment of non-life-threatening injuries.Third Squad detectives, who suspect the house was targeted, are continuing the investigation.All four are scheduled to be arraigned Monday at First District Court in Central Islip.last_img read more

Two Injured When Car Drives Off Second Floor of Miami Building

first_imgTwo women were injured in Miami on Wednesday morning, when their Mercedes-Benz drove off the second-floor parking area of a building there, authorities said.The incident happened shortly before 11:30 a.m., near SW 58th Avenue and 8th St.Authorities say an employee at a nearby restaurant rushed to the scene to help rescue the women from inside the car.Fire Rescue then personnel took them to Jackson Memorial Hospital.A Miami Fire Rescue technical rescue team assessed the building and determined there is no need to stabilize any part of the area where the crash occurred.The roadway was closed in both directions near the scene after the incident.The cause of the accident remains under investigation.last_img read more

Column: ‘There’s better ways to conceal it.’

first_imgIn this April 23, 2014 photo taken from video and provided by ESPN, home plate umpire Gerry Davis touches the neck of New York Yankees starting pitcher Michael Pineda in the second inning of the Yankees’ baseball game against the Boston Red Sox at Fenway Park in Boston. Pineda was ejected after umpires found a foreign substance on his neck. (AP Photo/ESPN)The thing that has baseball folks riled up about Michael Pineda isn’t that he was trying to cheat. Everybody does that.It’s that he wasn’t trying hard enough.The Yankees right-hander got nabbed on the mound Wednesday night in Fenway with what looked like an oil slick’s worth of pine tar on the right side of his neck. He left the ump no choice. It had to qualify as the grossest violation ever of Rule 8.02(b), which says, “The pitcher shall not … have on his person, or in his possession, any foreign substance.”Everyone in baseball knew what the penalty is, too, even before commissioner Bud Selig made it official with a 10-game suspension — if only because it’s one of the most commonly flouted rules in the game.Usually a pitcher hides a dab behind his belt, or inside a sleeve, or else has the catcher conceal it behind a shin-guard and throw the ball back already prepared. There’s some debate whether you can load a baseball up with enough pine tar to make it dance. But more than a few pitchers, hitters and managers believe that a little isn’t a bad thing at all — especially on a cold night — since everybody benefits when a guy with a first-class fastball has a good enough grip to throw it around the plate. It’s what baseball mean when they talk about the game’s “unwritten rules.”Pineda’s real sin, then, was not knowing when to stop. There’s no doubt — and plenty of high-def evidence — that he had pine tar on his hands when he dominated the Boston lineup through six strong innings barely two weeks ago. The Red Sox knew it, too, since there was enough grumbling through the first four innings that when Pineda took the mound for the fifth, he’d dutifully washed his hands.This time, though, Pineda slathered on enough pine tar to scrawl “Suspend me!” with room to spare. It was so obvious that Red Sox manager John Farrell had to call him on it, even though Farrell passed up the chance to have the ump inspect Pineda in that April 10 game.Afterward, Farrell seemed embarrassed for Pineda — “I think there’s better ways to maybe conceal it,” he said — but there’s more than enough embarrassment to go around.Why Pineda didn’t try harder is a matter of conjecture. Asked the question “You know it’s illegal, right?” he began his answer “Yeah, but …” then followed up by adding, “I don’t feel the ball and I don’t want to hit anybody.” Pineda also promised it wouldn’t happen again.Oddly enough, that’s probably as close to the truth as we’re likely to get. Pineda is just 25, from the Dominican Republic, and he comes into the season still learning English and freighted with expectations after sitting out the last two because of shoulder surgery. Chances are good he can tick off as many of baseball’s “unwritten rules” as you can, let alone the nuances of any.Maybe he figured he got away once going 10 mph over the speed limit, so this time he’d try 25 over. Beyond that, as a pal pointed out, if there’s another reason for Pineda’s behavior, trying to figure it out is likely a losing proposition.Tougher to figure out, though, is the Yankees’ responsibility in this mess. Presumably, someone in the organization explained the problem to Pineda after his first start against the Red Sox, which made manager Joe Girardi’s feigned surprise after this episode less than satisfying.“It’s something Michael chose to do after the first inning,” Girardi said. “He had a hard time gripping the baseball.”But that doesn’t explain how Girardi, pitching coach Larry Rothschild, or even catcher Brian McCann, who caught Pineda’s warm-up pitches, let the pitcher stand the mound wearing half a necktie fashioned from goo. Especially considering the already depleted ranks of the team’s starting pitching.“We as an organization are embarrassed,” general manager Brian Cashman. “He should not have been allowed out of our dugout like that.”Notice that no one has said Pineda shouldn’t have been using pine tar, only that he should not have been using it so obviously that he got caught. All that did was make it harder for the next pitcher to get away with a dab of pine tar, and spark what will probably be another round of retaliation as managers call for more inspections of pitchers. Like the game isn’t slow enough already.But that’s the problem with having one set of rules on the books, and another set for how the business is run day to day. Not everyone in the game agrees on what cheating is, but nearly all of them know it when you rub it in their face — or in this case, on your neck.___Jim Litke is a national sports columnist for The Associated Press. Write to him at jlitke@ap.org and follow him on Twitter at —https://twitter.com/JimLitkelast_img read more

About Town

first_imgRUMSONThe Rumson Country Day School will hold its 44th annual rummage sale, A Whale of a Sale, from 9 a.m. to 4 p.m. Saturday, April 20, and from 10:30 a.m. to 2 p.m. Sunday, April 21, at the school, located at Bellevue Avenue and Ridge Road.Each year, parents and many of the students, faculty, administration, staff, alumni, and friends work together to collect, sort, and display a huge assortment of items in the school’s Blake Gymnasium. The job is such a large undertaking that collection of the items for sale often begins months in advance.The rummage sale is one of the most important fundraisers at The Rumson Country Day School, as all proceeds of the sale are devoted to the financial aid program, providing financial assistance to many children who attend the school. The best selection and bargains will be found on Saturday, April 20. Those attending on Sunday, April 21, will be able pay one price and fit all they can into a bag provided by the school.During the week prior to the sale, the gymnasium becomes a beehive of activity as trip after trip is made to stock the gym with donated items. The donations are carefully sorted to cull the best items for the special boutique sections of women’s and children’s clothing and accessories. In addition, the silent auction area is stocked with furniture, antiques, china, crystal and collectibles.Not to be missed is the wide assortment of women’s, men’s, and children’s clothing at incredible bargain prices. Particularly popular is the sporting goods section where the selection often includes golf clubs, ski and hockey equipment, and exercise apparatus.Like any good rummage sale, there is also a huge selection of home furnishings, kitchenware, general home goods, bric-a-brac and toys. There will also be a large book section where attendees can stock up on current novels, cookbooks, children’s books, how-to books and more. The Community Foundation of New Jersey has announced that The Jonathan Maslow Scholarship, which it administers on behalf of members of the Red Bank Regional High School (RBRHS) Class of 1966, is accepting applications for the fall 2013 term.The Jonathan Maslow Scholarship is open to all RBRHS juniors and seniors who plan to continue their education at an accredited 2 or 4-year college immediately following their graduation.Scholarships will be awarded to students exhibiting exceptionally high levels of written proficiency, creativity, and originality, as well as an interest in local or national environmental causes, journalism or creative writing.The scholarship award is $5,000.Maslow, a 1966 graduate of RBRHS, was an accomplished author, journalist, documentary filmmaker, naturalist and environmentalist.  At the time of his death in 2008 he was an editor and columnist for the Herald News in Paterson. His accomplishments as a journalist and his commitment to his community are reflected in the many awards bestowed on him, including The New Jersey Press Association for Responsible Journalism and the Joseph M. Sklenar Editorial Award.Never one to shy away from a challenge, Maslow covered civil strife in Central America, helped save a library in the City of Passaic, fought vigorously to help clean up the Passaic River and championed efforts to make politicians accountable for their actions.Any student wishing to obtain an application may do so at www.cfnj.org.The deadline for applications is April 13.For more information or with questions, please contact Faith Krueger at the Community Foundation of New Jersey at 973-267-5533. MIDDLETOWNThe Art Society of Monmouth County will feature a demonstration from 11 a.m. to 1 p.m. Wednesday, March 20, by professional photographer Michael Dellert at the Middletown Public Library, New Monmouth Road.Dellert will discuss and show his professional photography techniques and answer any questions. He’s a graduate of Penn State School of Fine Arts.Admission is free and open to the public. Refreshments will be served. WEST LONG BRANCHMonmouth University’s Jewish Cultural Studies Program presents the Honorable Daniel Kurtzer from 7:45 to 9 p.m. Tuesday, March 5, in Wilson Hall Auditorium.Kurtzer served as U.S. ambassador to Israel from 2001-2005 and as U.S. ambassador to Egypt from 1997-2001. Currently a professor of Middle Eastern Policy Studies at the Woodrow Wilson School of Princeton University, Kurtzer will discuss the current situation in Middle East.The event is free of charge and open to the public.Organized by the Jewish Cultural Studies Program and the Office for Global Initiatives, the event is co-sponsored by the Jewish Federation of Greater Monmouth County.For more information please contact 732-571-4474.Monmouth University appreciates the generosity of a group of Hollywood Golf Club members who enable multiyear support for the Monmouth University Jewish Cultural Studies Program. Middletown Lions ‘Roar for the Shore’ with DonationMembers of the Middletown Lions Club recently presented a check for $2,000 to officials for the township’s disaster relief fund. The money was the proceeds from the organization’s annual pancake breatfast, held just before Super Bowl Sunday last month.Middletown Lions Club President Larry Caminiti, left, presents a check to Mayor Gerry Scharfenberger, center, and Committeeman Tony Fiore for the Middletown Disaster Relief Fund. The money was raised through the Lions’ annual pancake breakfast.The Lions, appropriately, decided to ‘roar for the shore’ and support the Middletown Disaster Relief Fund, a charitable organization started by former mayor and current Township Committeeman Tony Fiore to assist Middletown residents impacted by Super Storm Sandy. Event Chair Lion John Giordano said the Middletown Lions Club has a long-standing tradition of responding to the immediate and urgent needs of the community.“In light of the destruction caused by the storm, the club did not question that the funds from the breakfast should be dedicated to helping our friends and neighbors in Middletown this year,” Giordano said. “We want to do whatever we can to help residents restore their lives and their homes.”The check was presented to Mayor Gerry Scharfenberger for the disaster fund during the township committee’s Feb. 19 meeting.“The Middletown Lions Club is always there for the community,” Scharfenberger said.Information on the Middletown Disaster Relief Fund is available at www.middletownnj.org and mwww.middletownrelief.com or by calling the mayor’s office at 732-615-2024.The Middletown Lions Club, chartered in 1946 through Lions International, is a volunteer service organization consisting of men and women who help the community through charitable service projects and fundraising initiatives and programs. The club meets on the second and fourth Tuesdays of the month. For more information, visit the website at www.mlions.org.center_img * * * * *A few years ago a group of dedicated volunteers began getting together to tend to the rose beds at Riverside Gardens Park on Front Street.The rose beds had suffered from years of neglect and volunteers spent hours cutting back the roses, removing dead wood, weeding, and digging out invasive vines. Scouts, high school students and community members have worked at the gardens dozens of times throughout the growing season.All this hard work pays off and the roses flower beautifully every spring and summer for months on end.The friends of Riverside Gardens will meet at the park from 9 a.m. to 1 p.m. Saturday, March 9, for the first time this year. All members of the community are invited to join in helping to maintain and improve this valuable public treasure. Participants are asked to wear warm clothes and work gloves. Bottled water will be provided.The rain date is March 16. For more information, contact Bob Hespe at hespeb@aol.com. RED BANKAs part of its Community Haiti Response Initiative, Pilgrim Baptist Church of Red Bank is sponsoring an Adopt-A-Family Program to feed families in the community of La’Cajou, Haiti.A donation of $250 means the sponsor can provide a 50-pound bag of rice and fuel every three months for a year to a family in need in Haiti.The church’s Haiti Response Initiative has partnered with Aslan Ministries, Lott Carey Foreign Mission Convention and the Seacoast Missionary Baptist Association to facilitate the program.Sponsorship registration forms and additional information is available by calling 732-747-2343. Scholarship Opportunity Available for RBR Studentslast_img read more