Generic News

MARCH 18, 2012

New Legislation Aims to Make Generic Opioids Tamper-Resistant

New federal legislation aimed at controlling prescription drug addiction and abuse was recently proposed by US Representative William Keating (D, Massachusetts).

The bill seeks to require that manufacturers of the generic versions of OxyContin (oxycodone) and Vicodin (hydrocodone) make their formulations of the painkillers tamper- and crush-resistant. Proponents of this legislation hope to mandate that bioequivalents have the same protections as their brand-name predecessors in order to gain FDA approval.

According to data from the Centers for Disease Control and Prevention, the increase in unintentional drug overdose death rates in recent years has been driven by increased use of opioid analgesics. Since 2003, more overdose deaths have involved opioid analgesics than heroin and cocaine combined. Abusers alter oral pain medications to get more of the drug into their systems at a faster rate.

Abusers crush up the pills to snort them or smoke them, or add water to them to inject them intravenously. In an effort to curb abuse of OxyContin, Purdue Pharmaceuticals released a reformulation in 2010 that deters this kind of abuse.

Supporters of Keating’s bill argue that such reformulations of brandname drugs, though effective, simply compel addicts to switch to the easierto-manipulate generic versions, which do not use tamper-resistant technologies. Supporters of the bill hope to get the legislation in place before more potent painkillers are released into the market. “We’re here today because there is an epidemic dealing with prescription abuse,” Keating said in a press conference. “This is one more strong tool in the arsenal we’ll be able to use to combat this terrible epidemic.”

Brand-Name Drugs Explain Regional Variation in Medicare Part D Spending

Preferences for brand name drugs rather than their generic equivalents help to explain geographic differences in Medicare Part D spending, according to a February 2012 report in the New England Journal of Medicine.

The investigators, led by Julie M. Donohue, PhD, analyzed 4,666,866 Part D beneficiaries from 306 geographic regions in 2008 and calculated their spending in 3 categories of drugs: angiotensin-converting enzyme (ACE) inhibitors and angiotensin receptor blockers (ARBs), statins, and antidepressants (selective serotonin reuptake inhibitors [SSRIs] and selective norepinephrine reuptake inhibitors [SNRIs]).

After adjusting for demographic, socioeconomic, and health status discrepancies among the regions, researchers determined that 76% of the regional variation was due to the cost per prescription filled; increased spending per region was due to brand loyalty rather than to the total volume of prescriptions filled per region. Regional variation within the 3 categories of drugs was also noted: differences in cost per prescription explained 87.5% of expenditure variation for ACE inhibitors and ARBs and 56.3% for statins, but only 36.1% for SSRIs and SNRIs.

Dr. Donohue and colleagues also noticed that in certain areas, such as Miami, Florida, patients consistently used a high percentage of brand-name drugs, whereas in other areas, such as Rochester, Minnesota, patients were rarely prescribed brand-name drugs within the 3 categories studied.

The researchers estimated that Part D spending could be reduced by $4.5 billion nationwide by choosing generic equivalents over brand-name medications. According to the report, “A reduction in branded-drug use in some regions through modification of Part D plan benefits might lower costs without reducing quality of care.”

GPhA Welcomes Hospira

Hospira, a specialty pharmaceutical and medication delivery company, announced in late February that it has joined the Generic Pharmaceutical Association (GPhA). Hospira focuses on specialty generic injectable pharmaceuticals and, like GPhA, hopes to increase availability of lower-cost drug alternatives without compromising quality.

Hospira currently offers approximately 200 injectable drugs encompassing the therapeutic areas of analgesia, anesthesia, anti-infectives, oncology, and others.

Membership in the GPhA is “open to the manufacturers and distributors of finished generic pharmaceutical products; manufacturers and distributors of bulk active pharmaceutical chemicals; and suppliers of other goods and services to the generic pharmaceutical industry,” according to the company website.

Ralph G. Neas, president and chief executive office of GPhA, expressed excitement about Hospira’s membership in a press release, saying, “Hospira’s products, like those of our members, have enabled millions of Americans to obtain affordable treatments for their conditions. Their input and participation will be a valuable asset for GPhA as we move into this new and exciting time for our industry.”

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