WASHINGTON – Still haunted by the deaths caused by contaminated heparin that made it into the U.S. drug supply a few years ago and the fact that no one has been held accountable, several senators are calling for drug safety to be elevated to a national security level while creating a level playing field for U.S. drugmakers.
"This is as important as protecting our borders," Sen. Barbara Mikulski (D-Md.) said in a Senate Health, Education, Labor and Pensions (HELP) Committee hearing Wednesday as she questioned whether the FDA is moving with the necessary sense of urgency.
Bringing adulterated drugs into this country is a form of murder, Mikulski said. To tackle the problem, the FDA must adopt the same attitude as the Department of Homeland Security – get the bad guys in their countries before they get American consumers here, she added.
Sen. Michael Bennet (D-Colo.) noted that most Americans assume the prescription drugs they take are made in the U.S. and that they have all been evaluated for safety. But the truth is 80 percent of the active pharmaceutical ingredients used in U.S. drugs and 40 percent of finished drug products are made outside the U.S., many of them at facilities that have never been inspected. The problem is growing as the numbers increase, allowing more opportunities for contamination, adulteration and counterfeits.
Possible solutions raised at the hearing, held as a precursor to reauthorization of PDUFA, included stiffer penalties, a uniform drug pedigree, risk-based inspections, requirements for drugmakers to audit their suppliers and new authorities for the FDA to mandate drug recalls and deny questionable products entry to the U.S. market.
Today, the penalty for counterfeiting a drug is lower than the penalty for counterfeiting a DVD, Bennet said.
And more is known about an individual bottle of milk sold at the grocery store than is known about a prescription drug a consumer picks up at the pharmacy, HELP Committee Chairman Tom Harkin (D-Iowa) said. He asked several experts testifying at the hearing about the feasibility of applying a simple bar code to a drug ingredient at the point of origin.
"Everyone along the line needs to be held accountable," he said. But to do that, regulators must know who is accountable every step of the way.
Gordon Johnston, senior adviser for regulatory sciences at the Generic Pharmaceutical Association, responded that it would be feasible domestically, but technology issues could create challenges internationally.
Marcia Crosse, health care director for the Government Accountability Office (GAO), agreed, saying that data systems would have to be aligned across the world for a bar code system to work. As it is, the FDA is still struggling to align its various databases and other information technology systems.
The GAO has been critical of the FDA's ability to protect the drug supply and has recommended several improvements.
Deborah Autor, the FDA's deputy commissioner for global regulatory operations and policy, testified that the agency has taken aggressive steps recently to implement the GAO's recommendations, but several obstacles remain. (See BioWorld Today, March 29, 2010.)
For instance, while the FDA is required to inspect domestic drugmakers every two years, the law is unclear about foreign inspections, she said. And in some countries, such as China, the FDA must receive a letter of invitation from the Chinese suppliers before it can get visas for its inspectors. That policy rules out the surprise inspections that domestic companies undergo.
Another inequity is that the FDA lacks authority to deny entry of questionable drugs. The agency needs the authority to ban the import of products from facilities that delay or refuse inspections, Autor said. In other countries, companies must demonstrate that their products are safe to gain entry. But in the U.S., the burden is on the FDA to show the products are unsafe.
Such inequities create a competitive advantage of noncompliance that needs to be eliminated to level the playing field for domestic drugmakers, Autor said.
To avoid unintended consequences, Martin VanTrieste, past chairman of Rx360, urged the committee to carefully evaluate legislative proposals. If solutions result in burdensome regulations or increased costs, they could force some sole sources of essential drug components out of the market, he said.
NIH Prepares for Potentially Deep Budget Cuts
As the congressional joint select committee on deficit reduction looks for ways to cut more than $1 trillion from the nation's debt, the National Institutes of Health (NIH) is looking for ways to survive what could be deep cuts in its budget.
In preparing their 2013 budget requests, the various NIH centers have been asked to develop scenarios for cuts as deep as 10 percent, Eric Green, director of the National Human Genome Research Institute (NHGRI), said this week.
Under a continuing resolution that's funding the government in lieu of a 2011 budget, the NIH received $30.9 billion this year, 1 percent less than it received in 2010, making it the first cut the agency has had in many years, Green told the NHGRI advisory committee. (See BioWorld Today, Aug. 31, 2011.)
President Barack Obama's proposed 2012 budget requested $32 billion for the NIH, which would be a 2.4 percent increase. Such an increase isn't likely, Green said. The best NIH can hope for given the current economy would be flat funding, but a 2 percent cut would be more realistic, he added. The worst-case scenario for 2012 would be a 5 percent cut.
It could be a while before the agency knows what its funding will be for fiscal 2012, which starts Oct. 1. So far, the House has passed six of 12 appropriation bills and the Senate has passed only one. With a recess planned for the last week of September, Congress plans to consider another continuing resolution next week.
SEC Creates Small Business Advisory Committee
Small biotechs are getting a new resource at the SEC – the Advisory Committee on Small and Emerging Companies.
The committee will provide a formal mechanism through which the SEC can get advice and recommendations specific to privately held small businesses and publicly traded companies with less than $250 million in public market capitalization.
"Our capital markets are a critical source of funding for emerging companies and smaller public companies," SEC Chairwoman Mary Schapiro said in a statement Wednesday. "That is why a key component in our agency's mission is to facilitate capital formation while at the same time protecting investors."
The new committee will advise the SEC on such issues as capital raising through private placements and public securities offerings, trading in the securities of small and emerging and small publicly traded companies, and public reporting requirements of such companies.
FDA Reorganizes Oncology Drugs Office
To provide better clarity and promote more transparent interactions with biopharma, the FDA has reorganized its office responsible for reviewing drug and biologic applications for cancer therapies.
Under the reorganization, the Center for Drug Evaluation and Research's Office of Oncology Drug Products has become the Office of Hematology and Oncology Products. The restructuring will allow a more disease-specific review approach.
The new structure contains four divisions: the Division of Hematology Products, Division of Oncology Products 1 (DOP1), Division of Oncology Products 2 (DOP2) and Division of Hematology Oncology Toxicology (DHOT). DOP1 and DOP2 will serve as the agency's primary review divisions for solid tumor therapies, and DHOT will review the nonclinical pharmacology and toxicology aspects of cancer therapies.