Patricia Van Arnum was executive editor of Pharmaceutical Technology.

Patricia Van Arnum

Access to capital, a burdensome and uncertain regulatory environment, and lack of innovation and productivity in R&D are the biggest threats to the biomedical industry’s growth during the next five years, according to biomedical company CEOs surveyed by the California Healthcare Institute (CHI), BayBio, and the management-consulting firm PwC US. 

CHI represents more than 275 biotechnology, medical device, diagnostics, and pharmaceutical companies, and public and private academic biomedical research organizations. BayBio is Northern California's life-science association, which supports the regional bioscience community through advocacy, enterprise support, and the enhancement of research collaboration. Its members include organizations engaged in, or supportive of R&D and commercialization of life-science technologies. CHI and BayBio worked with PwC to collect and administer data for the 2012 CHI, BayBio, PwC California Biomedical Industry Survey. The survey was conducted in November 2011 and targeted approximately 100 companies that conduct business in California in the areas of pharmaceuticals, biotechnology, medical devices, diagnostics or medical equipment.

Nearly three quarters (74%) of biomedical industry CEOs surveyed said their companies have had to delay a research or development project in the past year. 

Lack of funding was the top reason for project delays cited by private company CEOs, and accounted for more than one-third (40%) of delays by all public and private companies in the survey.

Eight in 10 CEOs surveyed agreed or strongly agreed that the current FDA regulatory approval process has slowed the growth of their organization. 

The CEO survey found that biomedical companies in California have sought diverse funding sources, divided almost evenly among government grants, angel investors, venture capital, licensing agreements, and partnerships. 
 “Biomedical companies have long relied on government grants and venture capital to finance innovation, but funding sources are shifting and companies will need to adapt to a new reality,” said Tracy Lefteroff, national life-sciences partner, PwC US, in a PwC US Jan. 10, 2012, press release. “While venture capitalists and angel investors will continue to be an important source of funding, it has become increasingly difficult for biomedical companies to gain access to them. Alternative sources of funding are emerging, which highlight shifting opportunities and dynamics in life sciences innovation.”


Other key findings from the survey showed:

Forty-four percent of biomedical CEOs surveyed said they will look to licensing agreements and corporate partnerships as a source of finance in the next 12 months, double the number of CEOs who last year said their companies are using this avenue for finance. 

Corporate-venture funding, the investment of corporate funds into external endeavors, is expected to become a much more crucial source of funding to the industry, with 30% of CEOs surveyed saying they will tap corporate-venture capital as a finance source in the next 12 months, versus only 10% who did so in the past 12 months.

Though still only a small contributor to the finance equation, disease foundations/nongovernmental organizations are growing as a funding source for 11% of CEOs who plan to use these funds in the next 12 months versus only 4%  who did last year.

Access to capital is seen by CEOs as the most influential state policy issue to keep biomedical research, innovation, and investment in California. Nearly three-quarters (72%) of CEOs said that access to capital is extremely important, followed by (in order of importance) tax incentives for innovation (60%), corporate taxation (51%) workforce preparedness (47%), and duplicative regulation among various state and federal agencies (37%).

 The need to seek alternative or nontraditional funding sources is supported by recent global biotechnology financing trends. According to a recent analysis by Burrill and Company, on a global basis, life-sciences companies raised a total of $82.4 billion during 2011 in public financings, up from $65 billion in 2010. Debt financings dominated fundraising in both 2010 and 2011 and accounted for the overall fundraising growth in 2011. Global life sciences public equity financings (initial public offerings [IPOs], private investment in public equity,, and follow-on offerings) totaled just $16 billion, a 7.9%  increase over the $14.8 billion raised in 2010, largely to follow-on financings in China, according to a Jan. 3, 2012, Burrill and Company press relese.

In the United States, public-equity financings in 2011 totaled $5.7 billion, down 17.4% from $6.9 billion a year ago. Fundraising slowed considerably in the US in the second half of the year as markets swung in the face of the European debt crisis and the debate in the US over the raising of the debt ceiling, the Standard and Poor's downgrade of U.S. credit, and the inability to reach agreement in Congress on how to reduce the budget deficit, according to the Burrill and Company release. 

A total of 16 life-sciences companies went public in the US 2011. Together, they raised $1.4 billion. That compares to 20 IPOs in 2010 that raised a total of nearly $1.4 billion. As a group, the life- sciences IPOs of 2011 fell 29% from their initial offering prices as of the close of the year. Ten of the companies that went public in 2011 did so below their target price ranges and, as a group, these companies sold nearly 28% more shares than they had set out to sell while raising about 13% less than they had hoped 

According to CEOs surveyed in the PwC US survey, FDA and regulation are the key issues affecting R&D. Eighty-one percent of CEOs also said that coverage and reimbursement issues are extremely important to the industry’s ability to advance biomedical research, innovation, and investment in California.  In addition, 80% of CEOs surveyed do not believe that FDA has the best regulatory-approval process in the world, and three-quarters believe that within five years, another country could conceivably recreate the system that has made the United States. the leading biomedical region in the world. 

Articles

Biopharmaceutical executives share their perspective on the key issues influencing growth and innovation.

Biopharmaceutical Executive Outlook

Ben Venue Laboratories is extending its voluntary suspension of manufacturing at its Bedford, Ohio, facility. The company had originally announced the suspension on Nov. 19, 2011, and announced the extension of the suspension on Dec. 23, 2011. 

Ben Venue had suspended manufacturing at the Bedford facility after an internal review indicated that routine preventive maintenance and requalification of some manufacturing equipment was overdue. These issues also were noted in recent inspection findings by FDA, the European Medicines Agency, and other global regulatory agencies. Ben Venue’s operations in Bedford include sterile injectable facilities with aseptic filling, lyophilization, and cytotoxic manufacturing in four factories.

The company says it is looking to restore some manufacturing in the first quarter of 2012. “As we address the facility and equipment issues in each factory, we will resume production, likely one line at a time,” according to a Dec. 23, 2011, 

. “We are now working to restore some manufacturing in the first quarter of 2012 and will provide updates as they become available.” The company says it continues to conduct a site-wide assessment in order to fully understand the potential impact and implement any appropriate corrective actions that may be needed as quickly as possible.

Ben Venue, however, said that the resumption of certain other manufacturing activities will take longer. “A substantial investment of time and resources will be required to make necessary improvements in the north facility, where several sterile injectable drugs currently in short supply are manufactured,” according to the company statement. “The facility requires major reconstruction that may take up to nine months to complete. We anticipate that no products manufactured in the north facility will be available to patients and healthcare professionals before the fourth quarter of 2012. It should be noted that these expectations are based on our current plans and may be revised in the future.”

Ben Venue Suspends Manufacturing at Bedford Plant

Drug Shortages Create Crisis for Manufacturers, Regulators

Ben Venue Laboratories is extending its voluntary suspension of manufacturing at its Bedford, Ohio, facility. The company had originally announced the suspension on Nov. 19, 2011, and announced the extension of the suspension on Dec. 23, 2011.

Ben Venue Continues Suspension of Manufacturing Activity at Ohio Facility

Producing pharmaceutical compounds in a cost-effective and operationally efficient way is an ongoing challenge for process R&D chemists. Improving product yield, purity, and enantioselectivity requires a myriad of approaches and tools to enhance process understanding and analysis. Some recent advances involve strategies for accelerating reaction discovery, approaches for inducing chirality and stereochemical analysis, and applications in nanotechnology for protein elucidation.   

Researchers at Princeton University recently reported on the use of "accelerated serendipity," a process involving robotics and high-throughput and automated workflow as a tool in process R&D. The researchers wanted to see whether serendipity could be forced or simulated to occur on a predictable basis in the realm of reaction discovery to provide a reliable platform to access valuable transformations or unexpected reaction pathways (1). The researchers used a high-throughput, automated workflow and evaluated a large number of random reactions and discovered a photoredox-catalyzed carbon–hydrogen arylation reaction for constructing benzylic amines, an important structural component within pharmaceutical compounds that is not readily accessed by means of simple substrates. The mechanism directly coupled tertiary amines with cyanoaromatics by using mild and operationally manageable reaction conditions. The researchers asserted that this carbon–carbon bond-forming protocol can be widely used in the synthesis of benzylic and heterobenzylic amines (1).  

"This is a very different way of approaching how we come up with valuable chemical reactions," said David MacMillan, professor of chemistry at Princeton University and co-author of the recent study, in a Nov. 28, 2011, Princeton University release. "Our process is designed specifically for serendipity to occur. The molecules that should be combined are those for which the result is unknown," he said. "In our lab, we used this technique to make new findings in a much more routine and rapid fashion, and we show that if you have enough events involved, serendipity won't be rare. In fact, you can enable it to happen on almost a daily basis." 

MacMillan conceived of accelerated serendipity following his doctoral work at the University of California–Irvine during the 1990s, according to the Princeton University release. When envisioning his team's recently reported project, MacMillan calculated that if, in a single day, he ran the equivalent of one reaction per day for three years—nearly 1100 reactions—the odds favored a new discovery, according to the release. The Princeton University researchers began running reactions once a day using a high-throughput, automated reaction accelerator in Princeton's Merck Center for Catalysis.  

A key part of the process was applying photoredox catalysis, an approach to synthesize chemical reactions using a low-power light source, according to the university release. MacMillan had earlier reported on the use of photoredox catalysis with organocatalysis in the direct asymmetric alkylation of aldehydes (2). The use of photoredox catalysts in organic-compound synthesis is relatively new comparative to other chemocatalytic approaches and broadened the compounds and reactions under study. For their latest work, MacMillan and his team carried out this process on the molecules before each reaction cycle. In the case of the researchers' recent work, the focus was on benzylic amines, important in many pharmaceutical compounds.  

"We quickly realized that any pharmaceutical research chemist could immediately take these very simple components and, via a reaction no one had known about, start assembling molecules with an adjacent aromatic ring rapidly," MacMillan said in the university release. "Instead of having to construct these important molecules circuitously using lots of different chemistry over a period of days if not weeks, we can now do it immediately in the space of one chemical reaction in one day," he said.  

 Researchers at Case Western Reserve University developed a "top-down" approach to introduce chirality into a nonchiral molecule by using a macroscopic blunt force to impose and induce chirality. "The key is that we used a macroscopic force to create chirality down to the molecular level," said Charles Rosenblatt, professor of physics at Case Western Reserve University in Cleveland, Ohio, in a December 2011, press release and senior author of a recent paper on the research (3).  

Specifically, the researchers imposed a macroscopic helical twist on an achiral nematic liquid crystal by controlling the azimuthal alignment directions at the two substrates (3). On application of an electric field, the director rotates in the substrate plane. This electroclinic effect, which requires the presence of chirality, is strongest at the two substrates and increases with increasing imposed twist distortion (3).  

Formulation development forum: nanosized dendrimers 

The researchers treated two glass slides so that cigar-shaped liquid crystal molecules would align along a particular direction. They then created a thin cell with the slides, but rotated the two alignment directions by approximately a 20-degree angle, according to the university release. The 20-degree difference caused the molecules' orientation to undergo a right-handed helical rotation, or a so-called imposed "chiral twist." Because of the higher energy needed to maintain the naturally left-handed molecules in the crystal, some of the left-handed molecules in the crystal became right-handed, with this shift being the induced chirality. To test for chirality, the researchers applied an electrical field perpendicular to the molecules. If there were no chirality, there would be nothing to see. If there were chirality, the helical twist would rotate in proportion to the amount of right-handed excess. The result was a model involving a trade-off among bulk elastic energy, surface anchoring energy, and deracemization entropy that suggested the large equilibrium director rotation induced a deracemization of chiral conformations in the molecules or  "top-down" chiral induction (3). 

. Researchers at Carnegie Mellon University successfully used nuclear magnetic resonance (NMR) to analyze the stereochemical structure of gold nanoparticles, a potentially important advance in drug development. Determining a nanoparticle's chirality is a key step toward developing them as chiral catalysts. 

The researchers reported on the chirality in gold nanoclusters by NMR spectroscopic probing of the surface ligands. The Au

Ph) were used as representative models for chiral and nonchiral nanoclusters, respectively (4). The researchers compared the NMR signal from the hydrogen atoms in the nonchiral gold nanoparticle with the NMR signal from the hydrogen atoms in the chiral gold nanoparticle. The NMR method overcame the limitations of circular dichoism spectroscopy in determining the chirality of gold nanoparticles in a racemic mixture. The nanoparticles' chiral core induced the methylene group's two hydrogen atoms to give off different frequencies, a phenomenon known as diastereotopicity.  

The researchers compared the NMR signal from the hydrogen atoms in the nonchiral gold nanoparticle with the NMR signal from the hydrogen atoms in the chiral gold nanoparticle. The nonchiral nanoparticle's NMR spectrum did not reveal any differences, but the chiral nanoparticle's NMR spectrum revealed two different hydrogen signals, providing a simple and efficient way of telling whether the particle is chiral or not, even for a 50/50 mixture of isomers, according to a Dec. 7, 2011, Carnegie Mellon University release. The researchers concluded that NMR spectroscopy can be a useful tool for investigating chirality in gold nanoclusters. Since the diastereotopicity induced on the methylene protons by chiral nanoclusters is independent of the enantiomeric composition of the chiral particles, NMR can probe the chirality of the nanoclusters even in the case of a racemic mixture while circular dichroism spectroscopy is not useful for racemic mixtures (4). 

Interdisciplinary approaches in chemistry, biology, polymer science, and the new sciences, such as nanotechnology, are important in advancing drug development and drug delivery. Researchers at the University at Buffalo have synthesized tiny, molecular cages that can be used to capture and purify nanomaterials. The traps are derived from a special kind of molecule, so-called a "bottle-brush molecule," which consists of small organic tubes whose interior walls carry a negative charge. This feature enables the tubes to selectively encapsulate only positively charged particles, according to a Dec. 5, 2011, University of Buffalo press release. The researchers reported on the new method for fabricating amphiphilic organic nanotubes from multicomponent bottlebrush copolymers with triblock terpolymer side chains. The obtained nanotubes were highly selective carriers for positively charged molecules and nanometer-size macromolecules by means of liquid–liquid extractions. The researchers were able to discriminate between dendrimers with about 2 nm size differentials (5). These kinds of cages could be used, in the future, to expedite tasks, such as segregating large quantum dots from small quantum dots or separating proteins by size and charge. 

"The shapes and sizes of molecules and nanomaterials dictate their utility for desired applications," said Javid Rzayev, assistant professor of chemistry at the University of Buffalo and co-author of the study, in the university release. "Our molecular cages will allow one to separate particles and molecules with predetermined dimensions, thus creating uniform building blocks for the fabrication of advanced materials."  

To create the traps, Rzayev and his team first constructed a special kind of molecule called a bottle-brush molecule. These resemble a round hair brush, with molecular "bristles" protruding all the way around a molecular backbone, according to the university release. After stitching the bristles together, the researchers hollowed out the center of each bottle-brush molecule, leaving behind a tube-like structure. When building the bottlebrush molecules, the scientists constructed each molecule using molecular structures that disintegrate upon coming into contact with water and around this core, attached a layer of negatively charged carboxylic acid groups. To design the molecule, the scientists immersed it water, in effect hollowing the core. The resulting structure was the trap, a nanotube whose inner walls were negatively charged due to the presence of the newly exposed carboxylic acid groups, according to the university release.  

To test the tubes' effectiveness as traps, the researchers designed a series of experiments involving a two-layered chemical cocktail, according to the university release. The bottom layers consisted of a chloroform solution containing the nanotubes, and the top layer consisted of a water-based solution containing positively charged dyes. After shaking, the nanotubes collided with and trapped the dyes, bringing the dyes into the chloroform solution. In similar experiments, the researchers used the nanotubes to extract dendrimers from an aqueous solution. The nanotubes were designed so that dendrimers with a diameter of 2.8 nm were trapped, and dendrimers that were 4.3 nm across were left in solution. To remove the captured dendrimers from the nanotubes, the researchers lowered the pH of the chloroform solution, which shut down the negative charge inside the traps and allows the captured particles to be released from their cages, according to the university release.  

 1. A. McNally, C.K. Prier, and D.W.C. MacMillan 

 485 Route One South, Bldg F, First Floor, Iselin, NJ 08830 tel. 732.346.3072, 

Some recent advances involve strategies for accelerating reaction discovery, approaches for inducing chirality and stereochemical analysis, and applications in nanotechnology for protein elucidation.

Broadening the Toolbox in Drug Development and Analysis

Nanosized systems are important in drug delivery. Such nanosized systems include liposomes, nanocrystals, micelles, colloidal particles, quantum dots, and dendrimers. Dendrimers are class of synthetic macromolecules with highly branched, monodispersed, circular, and symmetrical architecture that are used as carrier molecules in drug delivery (1). Researchers at the Mayo Clinic in Rochester, Minnesota, Wayne State University in Detroit, Michigan, and John Hopkins Medicine in Baltimore, Maryland, recently reported on using hydroxyl-terminated polyamidoamine (PAMAM) dendrimer-drug conjugate nanodevices to treat age-related macular degeneration and retinitis pigmentosa (2).  

Dry age-related macular degeneration and retinitis pigmentosa are caused by neuroinflammation, which progressively damages the retina and can lead to blindness. The research tested the dendrimer delivery system in rats that develop neuroinflammation. The researchers showed that steroids attached to the dendrimers targeted the damage-causing cells associated with neuroinflammation but left the rest of the eye unaffected and preserved vision, according to a Dec. 13, 2011, Wayne State University press release.  

The principal authors of the study, Raymond Iezzi, MD, an ophthalmologist at the Mayo Clinic, and Rangaramanujam Kannan, PhD, a professor of ophthalmology at The Wilmer Eye Institute of Johns Hopkins, developed a clinically relevant, targeted, sustained-release drug delivery system using a simple nanodevice construct (2). The experimental work in rat models showed that one intravitreal administration of the nanodevice in microgram quantities could offer neuroprotection at least for a month, according to the press release. 

Because steroids have neuroprotective and anti-inflammatory properties, the researchers tried to deliver them precisely to the right target. The PAMAM dendrimers were used as drug delivery vehicles. “Dendrimers are tree-like, noncytotoxic polymeric drug delivery vehicles (approximately 4 nm),” explained Kannan in the press release. “Surprisingly, the activated microglia in the degenerating retina appeared to eat the dendrimer selectively and retain them for at least a month. The drug is released from the dendrimer in a sustained fashion inside these cells, offering targeted neuroprotection to the retina,” said Kannan. 

Upon intravitreal administration, the PAMAM dendrimers selectively localized within the activated outer retinal microglia in two rat models of retinal degeneration, but not in the retina of healthy controls. This biodistribution covalently conjugated fluocinolone acetonide to the dendrimer. The conjugate released the drug in a sustained manner over 90 days. According to the researchers, these studies suggest that PAMAM dendrimers (with no targeting ligands) have an intrinsic ability to selectively localize in activated microglia and to deliver drugs. Although the steroid offers only temporary protection, the treatment as a whole provided sustained relief from neuroinflammation. The patent-pending technology will be advanced further through a multi-university collaboration among Johns Hopkins, the Mayo Clinic, and Wayne State University, according to the release.  

 1. G. T. Tolia and H.H. Choi, Pharm. Technol. 

 2. R. Iezzi et al., “Dendrimer-Based Targeted Intravitreal Therapy for Sustained Attenuation of Neuroinflammation in Retinal Degeneration,” Biomaterials online, DOI 0.1016/j.biomaterials.2011.10.010, Nov. 1, 2011.

Nanosized systems are important in drug delivery. Such nanosized systems include liposomes, nanocrystals, micelles, colloidal particles, quantum dots, and dendrimers. Dendrimers are class of synthetic macromolecules with highly branched, monodispersed, circular, and symmetrical architecture that are used as carrier molecules in drug delivery.

Formulation Development Forum: Nanosized Dendrimers

Neglected tropical diseases (NTDs) remain a key target in global-health initiatives and late last month, the International Federation of Manufacturers and Association (IFPMA), an organization representing the research-based pharmaceutical industry, outlined the industry’s plan for donations to combat nine NTDs. At least one billion people worldwide—one person in seven — suffer from NTDs, according to IFPMA. 

Overall, the pharmaceutical has pledged 14 billion treatments between 2011 and 2020 to support the elimination or control of nine key NTDs (see Figure 1). These NTDs are human African trypanosomiasis, trachoma, fasciollasis, leprosy, schistosomiasis, onchoerclasis, soil-transmitted helminthiases, lyphmatic filariasis, and Chagas disease. The donations average1.4 billion treatments annually and build upon companies’ existing medicines donation programs. The pledge for donations comes in conjunction with an NTD collaboration comprised of pharmaceutical companies, the Bill & Melinda Gates Foundation, the governments of the United States and United Kingdom, international organizations, and endemic countries’ national governments. 

Number of treatments pledged by pharmaceutical companies between 2011â2020 to treat nine neglected tropical diseases. m is millions.Source: International Federation of Pharmaceutical Manufacturers and Associations (IFPMA). Figure 1 is courtesy of IFPMA.  

These donations follow a World Health Organization (WHO) announcement of new NTD targets to be achieved by 20201. WHO highlighted nine NTDs whose elimination or control is achievable with adequate supply and distribution of the relevant medicines. For maximum impact, these donations focus on those nine NTDs that represent more than 90% of the global NTD burden. 

“For decades individual pharmaceutical companies have researched, developed, and donated medicines to fight disease and improve patients’ lives,” said IFPMA Director–General Eduardo Pisani, in a Jan. 30, 2012, IFPMA press release. ,“Today the research-based pharmaceutical industry jointly pledges a further 14 billion treatments to help end these debilitating diseases. This is our commitment as partners to help end NTDs and improve patient health.” 

In addition to medicine donations, the research-based pharmaceutical industry supports the fight against NTDs with capacity-building efforts in developing countries and medical innovation, such as the R&D for new NTDs, and the World Intellectual Property Organization (WIPO)’s Re:Search initiative. WIPO Re:Search enables broad access to clinical-trial data, knowledge, expertise, compound libraries, and intellectual property assets with a view to encourage innovation for treating NTDs. The pharmaceutical industry was the second largest funder of R&D for neglected diseases in 2010, reaching more than $500 million, according to IFPMA. 

Pharmaceutical companies pledge donations of 14 billion treatments for the next decade to combat nine neglected tropical diseases.

Pharmaceutical Companies Target Neglected Tropical Diseases

The Generic Pharmaceutical Association (GPhA) has proposed a multistakeholder initiative to minimize current and future critical drug shortages. GPhA represents the manufacturers and distributors of finished generic pharmaceuticals, manufacturers, and distributors of bulk pharmaceutical chemicals, and suppliers of other goods and services to the generic industry. The announcement follows a series of Congressional, executive, and industry responses to address the recent problem of drug shortages.

The proposal, known as the Accelerated Recovery Initiative (ARI), is based on voluntary communication between an independent third party and stakeholders involved in the manufacturing and distribution of generic injectable medications currently in shortage. It is designed to use real-time supply and distribution information to be given to stakeholders, including, but not limited to, manufacturers, wholesalers, distributors, group purchasing organizations, and FDA, to provide a better understanding of current conditions and to expand the supply of critical medications.

“The generic industry has taken a leading role in responding to this crisis, and the ARI marks a significant step in those efforts,” said Ralph G. Neas, president and CEO of GPhA, in a Dec. 15, 2011, 

. “This type of multistakeholder collaboration is exactly what is required to respond to this crisis. While this remains a complex issue that cannot be solved overnight, the ARI would significantly enhance our ability to reverse the drug shortages currently afflicting patients and prevent further ones from occurring.”

The ARI calls for an independent third party to gather current and future supply information from stakeholders for products identified as meeting the critical criteria. That information will be used to determine current and potential supply gaps, with a focus on those products where a shortage is expected to last longer than 90 days. A high-level SWAT team will be formed within FDA with the ability to quickly respond to critical shortages and work with the current Drug Shortage Staff that was expanded through the drug-shortage initiative ordered by President Barack Obama.

This voluntary initiative will take place in conjunction with the work currently being done by FDA to expedite regulatory reviews and to work closely with manufacturers. “It will maintain robust competition and will not in any way deal with pricing information,” said GPhA in its statement. “It will also require prior acceptance by the Federal Trade Commission and the Department of Health and Human Services. The type of information gathered and disseminated will increase early visibility and communication between the FDA and industry relating to current and potential drug shortages.”

The ARI was discussed as part of GPhA’s 

 by Neas before the Senate Committee on Health, Education, Labor, and Pensions on Dec. 15, 2011. Neas acknowledged that while many factors contributed to the current drug shortages, roughly half of the reported shortages have been attributed to problems associated with the manufacturing and release of generic sterile–injectable products. He said that the ARI is being supported by both GPhA and non-GPhA members, which collectively account for approximately 80% of the generic sterile–injectable products sold in the US. The ARI seeks to address the most critical drugs among the 200 identified by the FDA Drug Shortage Staff.

President Obama Issues Executive Order to Reduce Drug Shortages

FDA and Department of Health Address Drug Shortages

The Generic Pharmaceutical Association has proposed a multistakeholder initiative to minimize current and future critical drug shortages. The announcement follows a series of Congressional, executive, and industry response to address the recent problem of drug shortages.