Today's formulators have a better understanding of pharmaceutical ingredients, novel strategies for facing challenges old
and new, computerized modeling methods, an increased interest in controlled and extended-release formulations, and more alternative
routes of administration and delivery (see Table I). 30
Table I: Progress in delivery systems*
One of the major stories to emerge during the past 30 years is globalization. In the pharmaceutical industry, this means that
drugs are now manufactured, if not discovered, widely throughout the world, and sometimes in countries that are less vigilant
than the United States in matters of safety and efficacy. Combine that with the other great phenomenon of the past 30 years—the
globalization of information via the Internet—and you end up with a dilemma.
Consumers conducting simple Internet searches discovered that many prescription drugs could be bought more cheaply online
from other countries. In addition, as drug products travel increasingly between various countries, it has become easier for
counterfeit products to enter the supply chain.
The rise in counterfeiting has led to increased interest in anticounterfeiting technologies. Most attention has focused on
radiofrequency identification (RFID). RFID tags are difficult for counterfeiters to copy and, unlike barcodes, do not require
a line of sight. This technology also creates an electronic pedigree (epedigree) that records the chain of custody from the
point of manufacture to the point of sale, making it easy to identify counterfeit products when they enter the supply chain.
Although RFID is encouraged by the US Food and Drug Administration, and several companies have participated in pilot studies
of the technology, there are still some kinks to iron out before RFID can be widely adopted in the industry. One of the main
problems is the lack of standardization of the chips so they can be read at every point in the supply chain. Currently, there
are more than 100 types of chips with a wide band of frequencies.30
No matter the technology, ingredients, or formulation a company has developed, in the end, it all boils down to regulation
if the company wants its innovation on the market. Survey respondents felt that the "finalization of GMPs (21 CFR 210 and 211)" in 1978 and "21 CFR Part 11" in 1997 had an equally high impact (75%) on overall regulation in the past 30 years, with several respondents crediting
GMPs as "landmark" policies that "changed the way we do business." Not only did the GMPs clarify standards for manufacturers—providing
less room for error and safer drugs for users—but they also enabled FDA to enforce regulations.
Table II: Top 5* Regulatory Actions 1977-2007
Close seconds to the GMPs and CFR Part 11 were the 1987 "Guidelines on General Principles of Process Validation" (70%) and the more risk-based "GMPs for the
21st century" (67%) intiative.