Amy Ritter was Scientific Editor, BioPharm International.

Amy Ritter, PhD

A bill introduced by Senators Scott Brown (R-MA), Ron Wyden (D-OR), and John McCain (R-AZ) on July 13, 2011, aims to encourage states to reduce Medicaid spending by offering financial incentives to substitute generic drugs for branded ones where possible. The bill, called the Affordable Medicines Utilization Act of 2011, encourages generic-drug substitution under Medicaid by allowing states to keep a portion of the savings they realize.

 issued by the American Enterprise Institute for Public Policy Research estimates that states overspent by more than $3 million by not using generic drugs where available. The report predicts that savings from generic drugs will increase in 2011–2012 when other widely used drugs lose patent protection. Brown, in a 

, called the bill “common sense.” In the same press release, McCain added, “This bipartisan proposal incentivizes state Medicaid programs to substitute generics for more expensive brand-name drugs, introducing real competition for reimbursement dollars and saving taxpayers’ hard-earned money.”

Supporters of generic drugs came out in favor of the bill. Bob Billings, executive director of the Generic Pharmaceutical Association, said in a 

, “This legislation is exactly the kind of solution those in Washington should look to when searching for ways to rein in our country’s health care spending.”

Teva Pharmaceuticals also expressed its support for the measure. “As the largest provider of generic pharmaceuticals in the United States, Teva has been and continues to be committed to providing patients with access to the life-saving medicines they need,” the company said in a press 

. “This legislation will encourage states to increase access to high-quality, low-cost pharmaceuticals for their Medicaid populations. At a time when state government officials are struggling to close their budget shortfalls, improving access to FDA approved generic medicines will help lower their healthcare costs while maintaining access to care.”

Articles

A bill introduced by Senators Scott Brown (R-MA), Ron Wyden (D-OR), and John McCain (R-AZ) on July 13, 2011, aims to encourage states to reduce Medicaid spending by offering financial incentives to substitute generic drugs for branded ones where possible.

Bipartisan Bill Introduced to Encourage Generic Drug Use in Medicaid

The negotiations under way to control government spending and reduce the deficit have the potential to impact pharmaceutical revenues. A proposal is on the table to increase drug rebates under Medicare Part D as a means of controlling the overall costs of the Medicare program. The Pharmaceutical Research and Manufacturers of America (PhRMA) is opposed to such measures, concerned that a decrease in revenues could damage a healthy and growing industry and that the ripple-effects from a slowdown in biopharmaceutical growth could negatively impact an already fragile economy. In a 

, PhRMA president and CEO John J. Castellani issued the following statement:

“At a time when the [US] is facing a jobs crisis, evidenced by the terrible employment numbers from last Friday, it is critical that our policymakers embrace dynamic and innovative business sectors such as the biopharmaceutical research sector and refrain from stifling job growth through shortsighted proposals such as government-mandated price controls in Medicare Part D.”

 to back its assertions. The report, commissioned by PhRMA and conducted by Battelle Technology, an independent research organization, examined the direct, indirect, and induced impacts of the biopharmaceutical industry on the US economy. Direct impacts are defined as the specific impact of biopharmaceutical sector expenditures in the first round of spending. Indirect impacts are the impact of expenditures by suppliers to the biopharmaceutical sector, and inducted impacts are the additional economic impact of the spending of biopharmaceutical sector employees and suppliers’ employees in the overall economy that can be attributed to the direct biopharmaceutical industry expenditures.

The report found that the industry directly creates 674,000 jobs and supports an additional 3.4 million indirect and induced jobs. It directly generates $19.8 billion in state, local, and federal taxes, and including indirect and induced sources, generates around $85 billion in tax revenue. The finding that there is a large multiplier effect, that expenditures and losses by the biopharmaceutical industry are magnified by impacts on the other industries it supports, leads to the report’s conclusions that a change in revenue (up or down) of $20 billion would result in a change in the economy as a whole of $58 billion.

According to Castellani, “The bottom line is we are at a critical time for our economy. We have to create jobs, not lose more. We have to support innovation, not interfere with the most innovative sectors of our economy. We must continue to improve the health of America’s seniors, not increase costs and erect barriers to promising scientific breakthroughs.”

Recent trends in the US biopharmaceutical industry suggest this is a pivotal area for potential job creation.

The Economic Contribution of the US Biopharmaceutical Industry

, entitled “Q11 Development and Manufacture of Drug Substances,” which is now available for comment according to a 

. The draft guidance was developed in conjunction with the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH), and describes approaches to developing process and drug substance understanding. It also provides guidance on what information should be provided in certain sections of the Common Technical Document (CTD). The draft guidance is intended to harmonize the scientific and technical principles relating to the description and justification of the development and manufacturing process of drug substances (both small molecules and biologics).

Comments on the guidance should be submitted before September 1, 2011. They can be submitted electronically to 

, or in writing to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

FDA issued a draft guidance, entitled "Q11 Development and Manufacture of Drug Substances," which is now available for comment according to a notice published on June 29, 2011, in the Federal Register.

FDA Q11 Draft Guidance Available for Comment

Members of the House Energy and Commerce Committee are expanding their investigation into the 2008 entry of contaminated heparin from China into the United States (US) market. Heparin contaminated with overly sulfated chondroitin sulfate was linked to adverse reactions and the deaths of dozens of patients. FDA determined that the contaminant was deliberately introduced, but neither the source of the contaminant nor those responsible has ever been identified. Members of the committee have sent 

 to 10 companies requesting further information on the Chinese heparin industry and the Chinese heparin supply chain. Those companies include Amphastar Pharmaceuticals, Momenta Pharmaceuticals, Siegfried USA, Sagent Pharmaceutical, APP Pharmaceuticals, Sanofi, Drug Source, Global Pharma Sourcing, Pacific Rainbow, and Sandoz.

, committee leaders wrote: “We believe there is substantial public interest in solving this case. More than 80 percent of the [US] unfractionated heparin supply is sourced from China and more than 16 percent of [US] pharmaceutical ingredients are imported from China. There is reason to believe all or some of the individuals responsible for the adulteration are still actively engaged in the Chinese pharmaceutical supply chain and pose a continuing threat to pharmaceutical products imported to the [US]. How the heparin came to be contaminated and the exact nature of the contaminant remain unknown. It is important to determine how the adulteration happened so that industry and government can take more effective proactive measures to reduce the risk of such adulteration in the future.”

Members of the House Energy and Commerce Committee are expanding their investigation into the 2008 entry of contaminated heparin from China into the United States market.

House Committee Expands Investigation into Tainted Heparin

Ortho-McNeil-Janssen, a subsidiary of Johnson & Johnson, initiated a voluntary recall of its antipsychotic medication Risperdal because of an unusual odor. The recall covers one lot of 3-mg Risperdal tablets and one lot of 2-mg risperdone tablets. Risperdone is a generic form of the drug. The Risperdal lot originally contained 16,000 bottles, but the company believes approximately 1600 remain on the market, and believes around 1200 of the original 24,000 risperdone bottles remain. The lot numbers associated with the recall can be found in the company 

The odor is caused by small amounts of TBA (2,4,6 tribromoanisole), a chemical associated with preservatives applied to wood and found in shipping pallets used for storing and shipping drugs. TBA is not thought to be toxic, but it produces a musty, moldy odor, and a small number of people has reported temporary gastrointestinal symptoms after exposure to the smell.

This event marks the latest in a string of recalls resulting from odors caused by TBA contamination. Lots of J&J’s anti-HIV drug Prezista were recalled in May, and lots of their anticonvulsant Topomax were recalled in April. The company has been working since January 2010 to minimize the risks of further contamination and now requires suppliers to certify that they do not use pallets made from chemically treated wood.

A subsidiary of Johnson & Johnson initiated a voluntary recall of its antipsychotic medication, Risperdal, due to an unusual odor.

J&J Issues Voluntary Recall of Risperdal

Nanotechnology is science involving particles less than 100 nm in size. It is an emerging technology that is finding applications in medical products, food packaging, and cosmetics. Nanoscale materials can have different chemical, physical, or biological properties than their conventionally-scaled counterparts. As a first step in providing regulatory clarity about the use of such technology, FDA issued a 

, titled “Considering Whether an FDA-Regulated Product Involves the Application of Nanotechnology” on June 9, 2011. The guidance lists points that FDA will consider when determining whether a product applies nanotechnology, and explains rationales for those points.

For products subject to premarket review, FDA intends to apply the points contained in the draft guidance, when finalized, to better understand the properties and behavior of engineered nanomaterials. For products not subject to premarket review, FDA will urge manufacturers to consult with the agency early in the product development process so that questions related to the regulatory status, safety, effectiveness, or public-health effects of these products can be adequately addressed. The guidance does not provide a regulatory definition of nanotechnology.

Comments and suggestions regarding the draft guidance should be submitted within 60 days of its publication in the 

. Written comments can be submitted to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Ln., Rm. 1061, Rockville, MD 20852. Electronic comments can be sent to 

. All comments should be identified with the docket number (FDA-2010-D-0530) listed in the notice of availability published in the 

An FDA guidance has provided information for products that involve the application of nanotechnology, and rationales for those points.