Washington Editor

WASHINGTON – Although the deadline has come and gone, biopharma is still in the dark about the regulations intended to shed light on how potential conflicts of interest are to be publicly reported.

Under the Sunshine Act, which was included in last year's Affordable Care Act, the Department of Health and Human Services (HHS) was supposed to draft regulations by Oct. 1 describing how drugmakers are to submit data about payments made to physicians and how the information will be made public.

As part of the rulemaking process, HHS was supposed to consult with industry, consumers and other interested parties to ensure that the information is presented in the appropriate context. HHS delegated the rulemaking responsibility to the Centers for Medicare & Medicaid Services (CMS).

Since companies must begin collecting the data in less than three months, they need to know the rules, Sens. Chuck Grassley (R-Iowa) and Herb Kohl (D-Wis.) said in an Oct. 3 letter to CMS Administrator Donald Berwick. The lawmakers demanded to know why the draft regulations aren't available yet.

"Prompt federal guidance is urgently needed to ensure a smooth path toward increasing disclosure, eliminating conflicts and ultimately providing patients with the tools they need to make informed health choices," they said.

While noting that many larger biopharma companies, universities and the National Institutes of Health have voluntarily begun to implement their own disclosure policies to comply with the new law, Grassley and Kohl said they're concerned that the lack of timely guidance will prove burdensome and costly for smaller companies. (See BioWorld Today, May 24, 2010, and Aug. 8, 2011.)

The Sunshine Act requires drug manufacturers to begin collecting data Jan. 1 on all payments made to physicians – including consulting fees, honoraria, travel and entertainment. Those payments, along with all ownership or investment interests held by physicians or members of their families, must be reported to HHS beginning March 31, 2013. Violations can result in civil monetary penalties ranging from $1,000 to $100,000.

As of Sept. 30, 2013, HHS must post the details of the payments and investment interests online. The public data will include the identity of the manufacturer, the physician and the drug associated with the payment.

"We are concerned that CMS' failure to implement the statutory provisions on time with clear guidance, standards and definitions will create confusion among both manufacturers and consumers," Grassley and Kohl told Berwick.

They also noted that there has not been adequate consultation with industry representatives or consumer advocates.

Korea-U.S. Free Trade Agreement a Step Closer

A free trade agreement between South Korea and the U.S., which has been in the works for more than four years, is heading toward its final hurdle.

The administration formally transmitted the agreement to Congress, which must approve it before it can be implemented. The trade agreement, signed June 30, 2007, would eliminate an 8 percent tariff charged on drugs imported from the U.S. It also calls for market-based pricing for drugs, regulatory transparency and the acceptance of drug test results performed in the U.S. (See BioWorld Today, Sept. 14, 2011.)

The Pharmaceutical Research and Manufacturers of America (PhRMA) welcomed the news and urged Congress to pass it this year.

"This agreement will contribute directly to increased U.S. exports and the expansion of highly skilled, well-paying jobs here in the U.S.," PhRMA President and CEO John Castellani said in a statement.

"We believe this agreement, particularly the transparency and intellectual property provisions, represents a 21st century standard that should be a model for other agreements," he added.

Drug Shortages Continue to Grow

In what seems to be almost a daily occurrence now, the FDA is adding more and more drugs and biologics to the shortage list.

One of the drugs added recently is paclitaxel injection (Taxol), which is used to treat a number of cancers, including breast cancer. Five companies currently market various dosages of paclitaxel injection, according to the FDA. Bedford Laboratories, Sandoz Inc. and Teva Pharmaceutical Industries Ltd. are experiencing manufacturing delays, and APP Pharmaceuticals Inc. and Hospira Inc. are not able to keep up with the subsequent increase in demand for their product.

Meanwhile, Genzyme Corp., of Cambridge, Mass., is continuing to ration global supplies of Cerezyme (imiglucerase for injection) due to a temporary decrease in yields and changes made to the company's product release processes and procedures.

In a recent "dear U.S. health care provider" letter, Genzyme said it anticipates the Cerezyme supply outlook to begin improving in February. Cerezyme is used to treat Gaucher's disease.

Genzyme, a Sanofi company, also has been unable to meet global demand for its Fabry disease drug Fabrazyme (agalsidase beta) due to ongoing manufacturing issues. The company expects to be able to distribute product made in its new manufacturing facility in the first quarter of 2012, it said in an Oct. 3 supply update. (See BioWorld Today, June 17, 2009, March 25, 2010, Jan. 12, 2011, and Feb. 17, 2011.)