Eight Question of the Day, September 22, 2013, Will the slow progress of Congress in passing legislation to deal with the compounding pharmacy problem have any impacts on whether some in the House and Senate get reelected? Would the passage of federal compounding legislation help them in getting reelected?

Third Question of the Day, September 22, 2013 In light of the fact very few state boards of pharmacy have started to strictly and swiftly enforce state compounding laws, regulations and rules against compounding pharmacies and pharmacists, why hasn't Congress taken prompt action to give the FDA much needed clearly defined authority over compounding pharmacies and pharmacists that are a danger to the public safety and health?

Smooth Sailing For FDA

By Britt E. Erickson, Cheryl Hogue

Volume 90 Issue 52 | p. 35
Issue Date: December 24, 2012

Congress made it a top priority this year to pass the FDA Safety & Innovation Act (S. 3187), a bill that reauthorizes FDA to collect fees from the pharmaceutical and medical device industries to help accelerate the review of new drugs and devices. After numerous hearings this year, the bill cleared both the House of Representatives and Senate in June and was then signed into law by President Barack Obama.

The legislation allows FDA to collect user fees from industry for five years, beginning in fiscal 2013. Such fees provide about 60% of FDA’s drug review budget and 20% of its device center budget. The bill also authorizes, for the first time, user-fee programs for generic drugs and biosimilars—the generic equivalents of biologic drugs. In addition, it permanently authorizes two programs aimed at increasing the safety and effectiveness of drugs and medical devices for children.

Concerns of drug shortages and the safety of an increasingly globalized drug supply chain also prompted lawmakers to tack on several regulatory reforms to the FDAuser-fee bill.

Also part of the user-fee law is a provision that criminalizes a host of designer drugs. The law bans virtually all synthetic marijuana compounds, two stimulants sold as bath salts, and nine hallucinogens called 2C substances for the two-carbon bridge that links a benzene ring and an amino group in these compounds.

FDA was on the congressional radar again this fall because of a multistate outbreak of fungal meningitis, linked to a Massachusetts-based compounding pharmacy that produced injectable steroids. Lawmakers questioned whether the agency has sufficient oversight of compounding pharmacies. Such pharmacies typically mix small batches of drugs and are regulated at the state level, whereas large-scale drug manufacturers are regulated by FDA.

Lawmakers believe that the pharmacy responsible for the meningitis outbreak, the New England Compounding Center, was operating as a drug manufacturer under the guise of a compounding pharmacy.

Hearings related to FDA oversight of compounding pharmacies were held in both the Senate and House after news of the outbreak. In addition, last month Rep. Edward J. Markey (D-Mass.) introduced H.R. 6584. The bill would preserve state regulatory authority for small compounding activities and ensure that pharmacies operating as drug manufacturers are regulated by FDA.

Earlier this month, House lawmakers sent a letter to the International Association of Compounding Pharmacies, questioning whether the industry group has a history of encouraging compounding ­pharmacies to impede FDA from evaluating their prod­ucts.

What Markey's Planned Federal Legislation Will Include

Lawmaker commends MA Governor, will introduce legislation addressing loopholes in federal oversight of compounding pharmacies

WASHINGTON, D.C. – Congressman Edward J. Markey (D-Mass.), senior member of the Energy and Commerce Committee, which has jurisdiction over the Food and Drug Administration (FDA), today released the following statement after Massachusetts Governor Deval Patrick and state public health officials announced they are taking steps to address the regulation of compounding pharmacies in the wake of the meningitis outbreak caused by contaminated drugs from the New England Compounding Center (NECC). The state announced the preliminary results of its NECC investigation, which found numerous violations of good sterile compounding practices and other problems, said that it will begin making periodic unannounced inspections of compounding pharmacies that prepare sterile injectable medications; require compounding pharmacies in Massachusetts to submit annual reports of production, volume and distribution of medications; require compounding pharmacies to report to the Board of Pharmacies all interactions with federal regulatory authorities; and form a special commission to examine best practices and advise the state on what changes should make in state law to further assure the public’s safety.

“It is now clear that the New England Compounding Center violated state law and endangered the health of countless patients. I commend Governor Patrick and state and federal officials for their ongoing investigation and for taking immediate and decisive action to update state practices. This is a deadly serious situation involving highly sensitive drugs and vulnerable patients, demanding the strongest response from state and federal authorities and Congress. The longer these compounding pharmacy loopholes are allowed to remain on the books, the longer patients are at risk. That’s why I plan to introduce legislation addressing the regulatory gaps identified by this investigation and strengthening oversight of compounding pharmacies. I look forward to working with my congressional colleagues in a bipartisan manner to move this legislation forward and ensure the safety of patients in the future.”

Rep. Markey plans to introduce legislation that will:

• Require compounding pharmacies to comply with basic minimum safety standards
• Ban pharmacies from compounding drugs using ingredients that are not approved by the FDA
• Require explicit distinction between compounding pharmacies and drug manufacturers
• Require compounding pharmacies to provide adverse event reports to the FDA
• Require a warning to patients using any compounded pharmaceutical that it has not been approved safe and effective by the FDA 

From here

Should New Federal Legislation Similar to the Safe Drug Compound Act of 2007 Giving the FDA Authority to Regulate Compounding Be Enacted in Light of the New England Compounding Center Meningitis Outbreak

The Safe Drug Compounding Act of 2007 was drafted as a Senate bill.  Its purpose was to redefine oversight and regulation of the practice of pharmacy compounding by giving power to the FDA to inspect all retail pharmacies that made or dispensed compounded medications and to determine whether or not compounded medications were medically necessary or  "essentially copies" of existing FDA-approved medications. The draft bill also would have taken a number of steps to inhibit the distribution of compounded medications beyond state lines by requiring compounding pharmacies to provide detailed documentation on all intrastate orders and asking state pharmacy boards to "discourage the distribution of inordinate amounts of compound drug products in interstate commerce."  The bill never passed.

Pharmacists and pharmacy organizations opposed the draft bill, expressing concern that the Safe Drug Compounding Act of 2007, would restrain the practice of compounding by giving the Food & Drug Administration authority to regulate compounding. A coalition of nine pharmacy organizations--the American Pharmacists Association, National Community Pharmacists Association, International Academy of Compounding Pharmacists (IACP), American College of Apothecaries, American  Society of Consultant Pharmacists, National Alliance of State Pharmacy Associations, Massachusetts Pharmacists Association, North Carolina Association of Pharmacists, and Kansas Pharmacists Association --  drafted a letter to the bill's expected sponsors. insisting that the draft legislation "would negatively impact patient access to necessary compounded prescription medications and create onerous, new requirements for prescribers and pharmacists" and urging that this draft legislation not be introduced.  The coalition of none pointed out the work of the U.S. Pharmacopeia, state boards of pharmacy, and the Pharmacy Compounding Accreditation Board (PCAB) and promised to work with Congress to address concerns about compounding.

Compounding critics, however, wanted the draft bill to pass, insisted that the act would clarify several issues that have been unclear since 1997 when the Supreme Court struck down portions of the FDA Modernization Act (FDAMA) dealing with compounding, and  claimed it would help correct the problems and dangers associated with pharmacy compounding.  The 2007  legislation was sponsored by Senator Ted Kennedy and co-sponsored by Senators Pat Roberts and Richard Burr.  The bill previously failed to become law.  Senator Richard Blumenthal (D-Conn.) called for stronger federal oversight of compounding pharmacies.  In a letter to the FDA, Senator Blumenthal states:

 “This tragic incident calls for stronger oversight, more exacting standards and stricter enforcement of consumer and patient protections related to compounding pharmacies. I remain particularly concerned that compounding, which is intended for individual patient special needs, may have grown more broadly in some instances, into widespread and multi-state distribution."

To read the entire letter click here.  Is federal legislation already in the works?  What should the federal legislation cover?  What should it not cover?  How board should it be?