@Risk

The US Pharmacopeial Convention (USP) has proposed a set of recommended best practices to help the pharmaceutical industry improve supply chain integrity and reduce risks of counterfeit or mishandled medicines.

Improvements like these are long overdue. As I reported last spring, research from PwC concluded that many pharmaceutical supply chains have suffered from what amounts to benign neglect. As a result, they are inefficient, under-utilized and ill-equipped to cope with new medicines, cost pressures and health reform expectations.

Sure, in today’s global economy relationships between suppliers and other business entities are often opaque and difficult to track, but clearly, it’s time for the pharmaceutical industry to step up to better ensure that medicines can be traced back to their original manufacturer, are not adulterated or counterfeited and are transported to their intended destination with their quality intact.

Too many companies have discovered the hard way that “willful blindness” only increases their culpability in the eyes of Federal agents, regulators who now are cracking down on businesses that aren’t compliant with the Foreign Corrupt Practices Act (FCPA).

Don’t take that kind of risk. Resolve that this is the year to start better managing your multiple supplier master databases as you monitor and mitigate supplier risk in a global operating arena.

“There is incentive for all players in the pharmaceutical industry—large and small companies, regulators and standards-setting bodies—to come to some agreement on hotbutton issues such as track and trace technology and, at the larger level, to codify what constitutes a solid, universal approach to global supply chain integrity,” said Praveen Tyle, Ph.D., chief science officer for USP.

USP’s proposed standard covers four main areas: (more…)

Last spring, European credit risk managers were somewhat optimistic about delinquencies across mortgages, auto loans and other credit products.

Now, much of that confidence seems to have evaporated.

The third European Credit Risk Survey, which was conducted by FICO and Efma in September, found that: (more…)

For anyone raising children, the last few weeks of summer are typically peppered with shopping trips for back-to-school supplies.  It’s a key season for retailers, typically second only to holiday shopping in December.

This year is proving to be no exception. Despite concerns about the volatile economy, a recent study by Deloitte found that nearly nine out of 10 consumers plan to maintain or increase their back-to-school spending. More specifically:

• 86 percent of the households surveyed expect to spend the same or more on back-to-school items this year.
• Even so, consumers said they will be vigilant about the cost of the items they plan to purchase. Three out of 10 (29 percent) consumers believe prices on new back-to-school merchandise are higher than a year ago, and nearly two-thirds (65 percent) said low prices are the most important retailer attribute for back-to-school shopping.
• More than half (55 percent) of those polled reported that they will buy only what the family needs, and more than one-quarter (26 percent) will reuse last year’s items due to concerns about the economy or their finances. Nearly three out of 10 (28 percent) will consolidate trips to save on gas.

Which inflation-related concerns could derail consumer spending this season? Seven out of 10 respondents cited higher food prices (72 percent) and higher energy prices (70 percent), followed by roughly half (51 percent) who pointed to the lack of improvement in the job market.

“Retailers need to be prepared for a consumer who is sensitive to prices, especially with the pinch households are feeling from higher gas and energy costs this summer,” said Alison Paul, vice chairman, Deloitte LLP and Deloitte’s retail & distribution sector leader. “Retailers should monitor customers’ reactions closely to recognize where they are flexible, and where promotions are necessary to drive traffic and generate purchases of higher margin products in the store.”

Deloitte also probed evolving consumer buying behaviors. The survey found that shoppers increasingly rely on mobile devices and social networks for brand information, discounts, etc. For example: (more…)

Earlier this month, the US Food and Drug Administration, together with its European and Australian counterparts, released two reports detailing the results of pilot programs focused on increasing international regulatory collaboration with regard to drug quality and safety.

One report reviewed the Good Clinical Practice (GCP) initiative and assessed the success of information-sharing and collaboration on inspections relating to clinical trials.

The second report reviewed the Active Pharmaceutical Ingredients initiative and presented results of the information-sharing among the FDA, Australia’s Therapeutic Goods Administration and for Europe, the EMA, France, Germany, Ireland, Italy, the United Kingdom and European Directorate for the Quality of Medicines & Healthcare (EDQM). Based on the shared information, the FDA was able to refine its decisions, such as whether to postpone or expedite certain inspections, and in some cases also prohibited imports into the US of a firm’s products based on negative findings from a European inspection. According to the FDA, the information-sharing and collaborative inspections were important milestones in establishing a sense of mutual trust and common purpose among the drug regulatory agencies involved.

In June, the FDA released Pathway to Global Product Safety and Quality, a report which unveiled a new strategy to meet the challenges posed by rapidly rising imports of FDA-regulated products and a complex global supply chain. This FDA report calls for the agency to: (more…)

Retail industry sales are up again, marking the 12^th consecutive month of increases.

According to data from the National Retail Federation, retail industry sales (which exclude automobiles, gas stations, and restaurants) in June increased 0.3 percent seasonally adjusted from May and 5.5 percent unadjusted year-over-year.

June retail sales (which include non-general merchandise categories such as autos, gasoline stations and restaurants) also rose. Those figures, released last week by the US commerce Department, increased 0.1 percent seasonally adjusted month-to-month and 8.4 percent unadjusted year-over-year.

The National Retail Federation says last month’s warm weather, lower gas prices and strong Father’s Day promotions put consumers in a spending mood. In particular: (more…)