Regulatory Roundup

Published on: 
Pharmaceutical Technology, Pharmaceutical Technology-07-02-2013, Volume 37, Issue 7

Compounding, tracking legislation moves forward

Compounding, tracking legislation moves forward

Bills setting new rules for drug compounding and distribution through the supply chain are moving forward in the House and Senate, but clear divergence on specific provisions makes the final outcome uncertain. A bipartisan Senate measure would give FDA greater authority to regulate a new category of commercial compounders-large-scale operators that sell risky injectibles across state lines without prior individual prescriptions, while leaving "traditional" pharmacy compounders under state law. The Senate Health, Education, Labor & Pensions (HELP) Committee linked this compounding bill to a measure establishing an electronic tracking system for prescription drugs, starting with lot-level tracking and shifting to a unit-level traceability system over 10 years.

The House recently approved legislation that establishes an "enhanced" drug-tracking system, but without any clear path to unit-level reporting. House Republicans, however, propose only minor changes to FDA control over compounders, claiming that the agency has sufficient authority to regulate illegal operators and should do that more effectively. Both House and Senate track-and-trace bills pre-empt state laws, which has drawn opposition from California members of Congress who oppose any federal drug-tracking system that is less stringent than the one set for implementation in California. Congressional leaders have talked about enacting legislation by August, but it may take longer.

Medicare drug pricing

The 10-year anniversary of the Medicare prescription drug program (Part D) has brought praise for how it has extended access to medicines for nearly 50 million beneficiaries, along with questions about its costs and limitations. An analysis by consultants Avalere Health for drugmaker UCB finds that Part D plans cover fewer anticonvulsant drugs than commercial insurance plans and impose higher cost sharing that limits access (1). Meanwhile, the Senate Special Committee on Aging has asked the Government Accountability Office (GAO) to examine Part D spending, oversight of coverage and pricing information, and the program's potential for fraud and abuse. Sen. Ben Nelson of Florida, chairman of the Committee on Aging, seeks support for legislation requiring drug manufacturers to pay Medicaid rebates on medicines provided to low income "dual eligible" beneficiaries. That policy is calculated to raise $140 billion over 10 years and faces strong opposition from pharmaceutical companies.



Overseeing China


Concerns about recent bird flu outbreaks and public health issues in China are drawing scrutiny from Congress and interest in bolstering FDA oversight of soaring food and drug imports from that country. Shipments of FDA-regulated products from China increased from 1.3 million entry lines in 2007 to 4.5 million in 2012, reported Steven Solomon, FDA associate director for global operations and policy, at a May hearing by the Congressional-Executive Commission on China. Solomon noted that FDA now has 74 active import alerts for Chinese food and drug products, which allow detention or refusal of entry into the US, and that the agency is collaborating more with the Chinese FDA (CFDA) to address concerns. FDA staffers meet regularly (by video conference) with Chinese counterparts to discuss economically motivated adulteration of products and have worked jointly to shutdown websites illegally selling unapproved drugs. CFDA has provided FDA's China office with a list of domestic pharmaceutical firms that failed to comply with GMPs, enabling FDA to target 61 violative firms shipping products to the US.

ARV supply chain

The President's Emergency Plan for AIDS Relief (PEPFAR) marked its 10th anniversary in May 2013, amid kudos for success in providing antiretroviral therapy to millions of stricken individuals in Africa and other nations, as well as calls for more effective and efficient treatment and care programs. So far PEPFAR has provided $1.2 billion in ARV drugs to some 5 million people, promoting the use of combination therapy and transforming the deadly disease into a manageable epidemic in some places. An April 2013 report from the Government Accountability Office notes the need for better controls and recordkeeping to ensure that ARV supply chains are secure and establish appropriate inventory controls and records to avoid shortages, waste and loss of inventory. The aim is to expand the program to serve 23 million eligible people, and further improvements in drug supply chains are "critical," the study concludes (2).

Shortages in TB treatments

Efforts to control and treat tuberculosis have been hampered by a shortage of first-line treatment isoniazid (INH), according to reports from the Centers for Disease Control and Prevention (CDC). Manufacturers have had problems obtaining active ingredient supplies, prompting production delays. Shortages in all TB drugs are even more severe in India and other regions, fueling a spread of multi-drug resistant TB strains as patients are forced to stop taking medicines. Manufacturers Sandoz and Teva have moved to ramp up production in response to a temporary shutdown at VersaPharm. A lack of clear procurement projections by government health programs, as well as low prices for these widely used drugs, have discouraged additional manufacturers to move into the TB drug market.


1. Avalere Health, An Analysis of Access to Anticonvulsants in Medicare Part D and Commercial Health Insurance PlanS, June 2013,

2. GAO, President's Emergency Plan For AIDS Relief: Drug Supply Chains Are Stronger, but More Steps Are Needed to Reduce Risks, GAO-13-483, Apr. 26, 2013,