|
Compounding Bill Slows Down
Senate Bill S 959, designed to increase the FDA's ability to oversee compounding pharmacies that distribute mass-produced preparations across state lines, will take more time than originally predicted. Senators Harkin and Alexander have been asking for a vote on the bill, and a congressional aide has confirmed that they are planning to "request that the bill, with a substitute amendment, be streamlined in the coming days." However, Senator Coburn has said that more review time was needed before the bill could be passed, and he was doubtful that obtaining input from industry representatives and other stakeholders could be achieved prior to the August recess.
http://www.cq.com/login?jumpto=doc/news-4322606
Study Results Show that Compounding Pharmacy Oversight Is Not Consistent
The authority to regulate pharmacies engaged in drug compounding is ''unclear'' and ''inconsistent'' at the state and federal levels, according to a new federal report. The Government Accountability Office also found that federal circuit court decisions have given the FDA different oversight authority in different parts of the country. The report was requested by democratic U.S. Reps. John Tierney of Massachusetts and Elijah Cummings of Maryland. Also in the report was the lack of consensus about whether compounding drugs in large quantities should fall under federal or state regulators and that from 2002 to 2012, FDA officials had to obtain 11 warrants to inspect drug compounders' facilities that had challenged the agency's authority.
http://www.boston.com/news/local/massachusetts/2013/08/01/study-compounding-pharmacy-oversight-inconsistent/Tm9VpMGVJF79z74ze2lIqO/story.html
GAO says Congress Should Consider Clarifying FDA's Compounding Authority
Citing the issue that two federal circuit court decisions have led to differing FDA authority in different regions of the country, the auditors concluded that the FDA's authority over drug compounding is "unclear."
The 50-page study's recommendations include a call for executive action as well as legislative action. The GAO stated that the FDA commissioner should take steps to consistently collect reliable and timely information in the agency's existing databases on inspections and enforcement actions associated with compounded drugs. The agency also suggested that the FDA's database should "clearly differentiate" those manufacturers of FDA-approved drugs that the agency inspects for compliance with GMPs "from those entities compounding drugs that are not FDA-approved and that FDA does not routinely inspect."
There are at least three bills being considered that attempt to address the regulatory holes; the House Energy and Commerce Committee held a hearing to examine two bills in the House from Reps. Morgan Griffith (R-Va.) and Edward Markey (D-Mass.) and one from Senate Health, Education, Labor and Pensions Committee Chairman Tom Harkin (D-Iowa). All three bills agree that traditional compounding should be regulated mostly by the states and should be exempt from certain FDA requirements that pertain to new drug approval, good manufacturing practices, and labeling.
http://www.modernhealthcare.com/article/20130731/NEWS/307319946/congress-should-consider-clarifying-fdas-authority-over-compounding#
Two More Deaths Result from Steroid Injections
Two more Michigan residents have died as a result of the fungal meningitis outbreak that began last year and has sickened about 750 people nationwide. The individuals had developed epidural abscesses or infections at the site of injection. The medication was made in May 2012 at the Massachusetts-based New England Compounding Center, and they shipped 17,000 vials of contaminated preservative-free methylprednisolone acetate to facilities in 23 states, leading to the deadly outbreak. Michigan was hit the hardest; with 264 people sickened and 19 died.
http://www.freep.com/article/20130729/NEWS06/307290114/fungal-meningitis-outbreak
Gifts More Than $10 Must be Reported by Physicians
Drug and device manufacturers and group purchasing organizations must now report payments or gifts in excess of $10 made to physicians in a yearly basis under the Physician Payments Sunshine Act. Also, these payments will be displayed on a public website beginning in the fall.
Exceptions apparently include the following:
- Gifts or payments valued at less than $10-unless the aggregate amount paid to the physician exceeds $100 annually
- General food and drinks offered to all participants at conferences or large-scale events
- Educational materials and items intended for use by or with patients
- Samples intended for patient use, including coupons and vouchers for obtaining samples
- Payments or other transfers of value to residents
http://www.medpagetoday.com/PublicHealthPolicy/Washington-Watch/40757
Eighteen More Arrested in China's Bribery Probe
The head of Glaxo's China facility left the country last month after four of his colleagues were detained as part of a government probe that has produced allegations of 3 billion yuan ($489 million) in spurious travel and meeting expenses as well as trade in sexual favors. This resulted in the China government's scrutiny being extended to other foreign drugmakers and local hospitals. Police in the central city of Zhengzhou are holding 18 Glaxo employees and some medical personnel.
http://www.bloomberg.com/news/2013-07-28/gsk-s-reilly-to-return-to-china-to-help-with-response-to-probe.html
Nasacort AQ Recommended for Over-the-counter Status by FDA Panel
Sanofi's allergy drug Nasacort AQ is sufficiently safe to be used without a prescription reported a panel of advisors to the FDA; the vote was 10 to 6 in favor. It should be noted that the FDA is not obliged to follow the recommendations of its advisory panels but typically does so. If the okay is given, Nasacort AQ would be the first intranasal corticosteroid to be sold over the counter in the U.S., while it is already sold OTC in 10 countries. In 2012, there were 1.7 million prescriptions for Nasacort AQ and its generics. Prior to the availability of generics, Nasacort AQ generated peak annual sales of $375 million, while last year sales were less than $100 million.
http://www.reuters.com/article/2013/07/31/us-sanofi-nasacort-idUSBRE96U1DK20130731
| 
