February 15, 2013
Health Science Post
India Post
35
www.indiapost.com
Republicans say FDA withholds key meningitis docs WASHINGTON: House Republicans are ing process. threatening to subpoena documents from ``FDA has produced no communications the Food and Drug Administration as part from staff and officials at FDA headquarof an ongoing investigation into whether ters, who were actually making the decithe agency could have prevented a deadly sions about how to address the situation,'' outbreak of meningitis caused by contami- according to the letter, signed by Chairman nated drugs. Fred Upton and four other Republicans. Republicans on the Energy and Com- They point out that the Massachusetts merce Committee said that the FDA has Board of Pharmacy, ``a much smaller entity three weeks to turn over internal documents than the FDA,'' produced all the documents concerning its oversight of the New En- requested by the committee before the gland Compounding Center. The pharmacy November hearing. produced a contaminated steroid, used Agency spokeswoman Erica Jefferson mainly to treat back pain, that is blamed for said that the FDA is working to respond to fungal meningitis that has killed 45 people the committee, and has turned over more and sickened more than 600. than 3,500 pages of documents to Congress The outbreak was first identified in September and Congress has been inThe FDA inspected the pharmacy vestigating the case since three times between 2002 and 2005 October. But their inquiry and issued a warning letter in 2006 has been slowed by the complex overlap of state ordering NECC to stop mass-producand federal laws and reguing drugs outside the scope of its lations that govern specialty pharmacies like the license. But regulators never shut the Framingham, Mass.-based operation down. At a November NECC. hearing, FDA Commissioner Margaret The FDA inspected the pharmacy three times beHamburg said the agency decided to tween 2002 and 2005 and defer the issue to Massachusetts issued a warning letter in Board of Pharmacy 2006 ordering NECC to stop mass-producing drugs outside the scope of its license. But regulators since October. never shut the operation down. At a No``These documents include corresponvember hearing, FDA Commissioner Mar- dence from FDA's district offices and FDA garet Hamburg said the agency decided to headquarters as well as inspectional docudefer the issue to Massachusetts Board of ments and adverse event records from the Pharmacy, which had more direct oversight 2002-2006 timeframe,'' Jefferson said in a of the company. statement. While the agency has turned over the The lawmakers say they will consider documents related to its inspections, Re- issuing a subpoena if the FDA doesn't turn publicans say they want to see internal over key internal memos related to the case memos about the agency's decision-mak- by Feb. 25. -AP
Cautious optimism on new health mandate Cont’d from page 32
``The potential was we'd have to choose between not providing health care for our employees or providing health care for our employees that violates our tenets. It should have never happened in the first place,'' Raglow said. Loren Gresham, president of Southern Nazarene University in Bethany, said he was cautiously optimistic about the effect the new ``opt out'' options will have on schools like SNU and other religious nonprofits. He said he remains concerned about Hobby Lobby's battle against the government-imposed mandate. ``For the nonprofits, at least initially, it sounds like it might help us a great deal, but we'll have to digest the fine print of it,'' Gresham said. Raglow added that it also troubled him that
businesses who have religious objections to the mandate must still comply with it. Hobby Lobby was disappointed with the proposal as well, said Kyle Duncan, one of the attorneys representing Hobby Lobby Stores Inc. in its federal court challenge of Affordable Care Act requirements. ``We remain committed to protecting religious liberty until the administration recognizes the conscience rights of all Americans,'' Duncan said. The proposed rule will not affect Hobby Lobby's legal challenge to the mandate, company attorneys say. Hobby Lobby has said it would rather incur hefty fines than provide insurance coverage for contraceptive pills. The federal government contends that religious freedoms don't apply to the company, because it is a secular, for-profit corporation. -AP
Bharat Family Clinic to open 30 clinics by 2015 NEW DELHI: Primary healthcare provider Bharat Family Clinic has said it would invest Rs 60 crore to open up to 30 clinics by 2015. "We will be opening around 30 Bharat Family Clinics by end of 2015. We will be investing Rs 60 crore for this," Bharat Family Clinic Chairman and MD Pradeep Handa told PTI. This is part of the company's long-term plans to establish a large network of outpatient primary care clinics across India, he added. When asked how the company plans to raise the finances for the expansion, Handa said: "Entire operation and expansion of these clinics in India would be financed through internal accruals." The company has also tied up with Johns Hopkins Medicine International for an advisory role in developing clinical programs, assistance with facility design and operation of the clinics besides training of
physicians. "The new facilities will adopt the outpatient primary care procedures and protocols of Johns Hopkins Community Physicians, and will feature diagnostic equipment and highly trained teams of health care pro-
viders," Handa said. Areas of specialty will include general internal medicine, obstetrics and gynecology, pediatrics, dermatology, endocrinology, gastroenterology among others, Bharat Family Clinic said. -PTI