Friday, September 27, 2013

Want to know who is Supporting Congress' Agreement on the Drug Quality and Security Act--Read this


WHAT THEY’RE SAYING: DRUG QUALITY AND SECURITY ACT

September 27, 2013
“This compromise legislation addresses the issues that led to the NECC tragedy, protects the physician-patient-pharmacist relationship, maintains critical patient access to compounded medications, and strengthens the pharmaceutical supply chain.” - NCPA
WASHINGTON, DC – Earlier this week, House Energy and Commerce Committee Chairman Fred Upton (R-MI) and Senate HELP Committee Chairman Tom Harkin (D-IA) announced bipartisan, bicameral legislation to address high-risk drug compounding practices and strengthen America’s pharmaceutical supply chain. H.R. 3204 – the Drug Quality and Security Act – builds upon the Energy and Commerce Committee’s extensive efforts to improve drug safety and help prevent a future public health crisis like the 2012 meningitis outbreak tied to the New England Compounding Center.
In addition to the bill’s introduction, momentum continues to build around this important effort as dozens of groups have voiced their support. A sampling of the support is provided below:
“This compromise proposal provides a balanced and effective approach to address critical and complex issues surrounding compounded medications, as well as strengthening our nation’s pharmaceutical supply chain. NCPA applauds the House for moving this legislation in expeditious fashion, and urge members to vote in favor of this bipartisan compromise. … NCPA commends the Congress for crafting bipartisan legislation that addresses the New England Compounding Center (NECC) tragedy, ensures quality standards for all compounded pharmaceuticals, and maintains patient access to vital compounded medications.”
“Cancer patients and providers support a pharmaceutical distribution system that will protect against the counterfeit medicines that have put cancer patients at risk in the recent past. Distribution system protections

another recall


The Compounding Shop: FDA News Release - Lack of Sterility Assurance of Drug Products

By Newsroom America Feeds at 11:00 am EasternUPDATED 09/27/2013. Budesonide solution, used for nasal irrigation, from The Compounding Shop may be contaminated and should not be used or administered to patients. Originally posted 05/08/2013http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMe

Highlights of Federal Compounding legislation Draft


Among other highlights, the legislation:
  • Distinguishes compounders engaged in traditional pharmacy practice from those making large volumes of compounded drugs without individual prescriptions. Compounders who wish to practice outside the scope of traditional pharmacy practice can register as outsourcing facilities, but those who choose to remain traditional pharmacies will continue to be primarily regulated by State Boards of Pharmacy as they are in current law.
  • Defines the Food and Drug Administration’s (FDA’s) role in oversight of outsourcing facilities.  Outsourcing facilities would be subject to FDA oversight in much the same way as traditional manufacturers.  FDA will know who these outsourcers are and what they are making, receive adverse event reports about compounded drugs, and have the authority and resources to conduct risk-based inspections.  The legislation will give providers and patients the option of purchasing product from outsourcing facilities that comply with FDA quality standards.
  • Offers providers and patients better information about compounded drugs.  The legislation directs FDA to make a list of FDA-regulated outsourcing facilities available on FDA’s website, requires detailed labeling on compounded drugs, and prohibits false and misleading advertising.
  • Clarifies current federal law regarding pharmacy compounding.  The legislation strikes unconstitutional provisions in current law, resolving the patchwork of current federal regulation and applying a uniform standard nationwide.
quoted from here

Thursday, September 26, 2013

Bicameral Pact Uses Market Forces To Push Compounders Toward Voluntary Federal Oversight Lawmakers late Wednesday (Sept. 26) struck a bicameral, bipartisan drug compounding agreement that departs from previous proposals by ditching volume limits and a three-part test in favor of a voluntary regulatory scheme for sterile compounders.

Are we there yet? Bicameral Congressional group posts news about a track-and-trace agreement September 26, 2013



Regulation of compounding pharmacies will be included in the new Drug Quality and Security Act
 
Confirming that, indeed, Congressional committees have been working hard behind the scenes to completea compromise draft legislation that will encompass both the longstanding effort for national rules on trackingpharmaceutical shipments, and the more recent effort to give FDA more authority to regulate compounding pharmacies, several Congressmen issued news releases on Sept. 25 announcing their success. The actual bill remains to be revealed, at least as of early on Sept. 26. 
 
Senator Tom Harkin (D-IA), chairman of the Senate Health, Education and Labor Committee, issued astatement that commended “the bipartisan spirit that brought this compromise proposal together” in the form of what will now be called the Drug Quality and Security Act.  “Today we are taking a notable step toward completing the important work of improving the security of our pharmaceutical supply chain and clarifying the regulation of drug compounding,” said a statement from Fred Upton (R-MI), chairman of the House Energy and Commerce committee. “This step will help us protect the health and safety of the American people,” said Energy and Commerce Committee Chairman Fred Upton (R-MI).
 
Interestingly, the issue of drug compounding seems to have superseded that of track-and-trace legislation in the discussions. The Senate bill put forward earlier this year included regulation of compounding; the House bill did not. Given that track-and-trace legislation has been debated and wrestled with since around 2006, while the compounding topic only appeared within the past year, there was a risk that the ongoing legislative efforts for track and trace could have been derailed by the compounding issue.

Continue to read here
 
 

FDA Law Blog - HHS Issues Refill Reminders Guidance Ahead of Compliance Deadline; FDA’s Fifth Annual Report to Congress on 505(q) Citizen Petitions



Last week, ahead of the September 23, 2013 compliance deadline for its HITECH final rule (also referred to as the “Omnibus Final Rule”), the Department of Health and Human Services issued guidance  entitled “The HIPAA Privacy Rule and Refill Reminders and Other Communications about a Drug or Biologic Currently Being Prescribed for the Individual.”  In prior posts, we discussed the HITECH final ruleherehere, and here.  The guidance, as you guessed it, addresses the refill reminder exception, from the Omnibus Final Rule, and its two prongs:  (1) whether the communication is about a “currently prescribed drug or biologic,” and (2) if the communication involves financial

Here is another viewpoint on compounded hormones and why women turn to them

New Legislative Draft Mixes Congressional Approaches on Compounding, Track and Trace

New Legislative Draft Mixes Congressional Approaches on Compounding, Track and Trace

Drugmakers would get more FDA scrutiny under draft bill By Steve Walsh, Bloomberg News

The U.S. for the first time would have uniform regulations to help identify stolen or fake drugs, and makers would get more scrutiny, under a draft bill from the Senate and House committees that oversee pharmaceutical safety. 

The measure would let the Food and Drug Administration collect and spend fees to cover costs of inspections and licensing. It also would impose handling and record-keeping requirements and create notification rules for drugs that are potentially unsuitable for distribution. 

The measure responds to regulatory gaps revealed by investigations into 50 meningitis-related deaths last year that resulted from tainted medications linked to a compounding pharmacy. It would replace a patchwork of state laws governing distribution of drugs through about 4 billion prescriptions a year filled by compounding and traditional pharmacies, the Senate Health, Education, Labor and Pensions and House Energy and Commerce committees said in a statement. 

"This legislation will improve the safety of compounded drugs by clarifying the oversight responsibilities of the FDA over large-volume compounders and by holding facilities to high quality standards," Iowa Democrat Tom Harkin, who heads the Senate committee, said in a statement. "This bill also calls for an unprecedented tracing system that will track prescription drugs from manufacturing to distribution." 

Counterfeit Imports 

The FDA said last year that it had discovered counterfeit versions of Roche Holding AG's cancer medicine Avastin -- with no active ingredient -- in boxes identifying the contents as Altuzan, Turkey's version of Avastin, which hasn't been approved for use in the U.S. In 2008 the FDA recalled Baxter International Inc.'s blood thinner heparin; during the crisis, neither the FDA nor Baxter was able to re-create the supply chain, taking weeks to get close to the source, according to a report last year by the Institute of Medicine, part of the Washington-based National Academies of Sciences. 

Under the proposed legislation, manufacturers, repackagers, wholesale distributors and dispensers would, within seven years, be maintaining and sharing records of key information about each drug's distribution history. 

The measure would let drug compounders register as outsourcing facilities subject to the same FDA oversight as traditional pharmacies. That would enable the FDA to identify providers and products, get reports on adverse reactions and make risk-based inspections. 

FDA Criticized 

The FDA came under criticism from Congress for failing to close New England Compounding Pharmacy Inc. before the company shipped fungus-tainted medications to customers across the U.S. in last year's meningitis outbreak. The company subsequently filed for bankruptcy. The FDA told lawmakers that its legal authority over compounding pharmacies needed to be clarified. 

The relevant committee chairmen and the panels' top minority members reached a rare bipartisan accord yesterday after the Republican-controlled House passed a supply-chain bill, H.R. 1919, and the Democratic-majority Senate panel approved compounding pharmacy legislation, S. 959. 

Compounding pharmacies prepare personalized prescriptions and are regulated by state health authorities. Some companies also produce larger amounts of blended medicines. 

A Senate committee staff report released in May found that in the eight months after the meningitis outbreak caused by contaminated compounded drugs, at least 48 compounding companies were found to be producing and selling drugs contaminated or created in unsafe conditions. In at least three cases, visible contamination was spotted in widely distributed sterile compound drugs. 

Documented Deaths 
continue to read   here

Drug compounding compromise reached, Lamar Alexander says House, Senate work out bill, but FDA may not support it Sep. 26, 2013 5:18 AM


A compromise bill that supporters say gives the U.S. Food and Drug Administration great regulatory control over drug compounders has been announced by congressional leaders from both the House and Senate, but it is unclear whether it has the support of the FDA itself.
The compromise was disclosed late Wednesday in news releases issued by U.S. Sen. Lamar Alexander, R-Tenn., and a bipartisan group of House leaders, including U.S. Rep. Henry Waxman, a California Democrat.
The agreement comes a year after the beginning of a fungal meningitis outbreak that took the lives of 16 patients treated in Tennessee and 64 nationwide. The deadly outbreak has been blamed on a Massachusetts drug compounding company that shipped fungus-tainted spinal steroids to health care providers in 20 states.
Industry officials said the compromise had been worked out over the weekend, but they expressed concerns the FDA had last-minute objections.
Erica Jefferson, FDA spokeswoman, said she could not immediately comment on the matter. Actual copies of the legislation were not immediately available.
continue to read here